Supplemental Evidence and Data Request on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition, 2609-2611 [2024-00618]

Download as PDF Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than February 15, 2024. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414. Comments can also be sent electronically to Comments.applications@chi.frb.org: 1. Northstar Financial Group, Inc., Bad Axe, Michigan; to acquire Mainstreet Community Bank of Florida, DeLand, Florida. Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. 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Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Jkt 262001 [FR Doc. 2024–00692 Filed 1–12–24; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Supplemental Evidence and Data Request on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition FEDERAL RESERVE SYSTEM 18:57 Jan 12, 2024 Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. Agency for Healthcare Research and Quality BILLING CODE P VerDate Sep<11>2014 Washington, DC 20551–0001, not later than January 31, 2023. A. Federal Reserve Bank of Philadelphia (William Spaniel, Senior Vice President) 10 Independence Mall, Philadelphia, Pennsylvania 19106. Comments can also be sent electronically to comments.applications@phil.frb.org: 1. Kenneth R. Lehman, Fort Lauderdale, Florida; to acquire voting shares of Blue Ridge Bankshares, Inc., Charlottesville, Virginia, and thereby indirectly acquire voting shares of Blue Ridge Bank, National Association, Martinsville, Virginia. Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submission. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition, which is currently being conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before February 15, 2024. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. Print submissions: Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 2609 Improvement Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301–427–1656 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition. AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a. The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/products/ effect-dietary-digestible. This is to notify the public that the EPC Program would find the following information on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition helpful: D A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. D For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to follow-up/withdrawn/ analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, E:\FR\FM\16JAN1.SGM 16JAN1 2610 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare. ahrq.gov/email-updates. The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. Key Questions (KQ) KQ 1: What is the association between dietary digestible carbohydrate intake and the incidence of type 2 diabetes (T2D) and effect on growth, size, and body composition (i.e., obesity, overweight, body weight and composition)? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting) ddrumheller on DSK120RN23PROD with NOTICES1 INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS) PICOTS elements Inclusion criteria Exclusion criteria Population ......... • Participants who are generally healthy, including participants who are determined to be overweight/obese, women who are pregnant or lactating. • Age of participants: Æ Between 2 and 9 years (before puberty) .. Æ Between 9 and 17 years ........................... Æ 18 years and older. Interventions ..... • Total dietary digestible carbohydrate intake from foods, beverages, and dietary supplements. Æ Total dietary digestible carbohydrate intake defined as collective starch and sugar intake; carbohydrate intake not including dietary fiber). • A dietary pattern that quantifies the intake of total dietary digestible carbohydrates and allows the isolation of the effect of carbohydrate intake from the effect of the intake of other macronutrients. Comparators ..... • Different total dietary digestible carbohydrate intake level(s). Outcomes .......... • Incidence of type 2 diabetes ............................. • Incidence of gestational diabetes. • Surrogate markers suggesting prediabetes or abnormal glycemia. Æ HbA1C level. Æ Glucose tolerance/insulin resistance/insulin sensitivity. • Growth, size, and body composition. Æ Body weight. Æ BMI. Æ Body circumference. Æ Body composition and distribution. Æ Classifications of underweight, healthy weight, overweight, and obesity. • Studies that enroll participants with diseases/health-related conditions that impact carbohydrate absorption or metabolism including cancer and malabsorption syndromes. • Studies that exclusively enroll participants hospitalized with an illness or injury. • Studies that exclusively enroll participants with type 1 or 2 diabetes (i.e., studies that aim to treat participants who have already been diagnosed with the endpoint outcomes of interest). • Studies designed to induce weight loss or treat patients who are determined to be overweight and obese through energy restriction or hypocaloric diets for the purposes of treating additional or other medical conditions. • Studies that exclusively enroll participants who are determined to be undernourished, underweight, stunted, or wasted. • Studies that enroll participants who are prebariatric or postbariatric surgery. • Exclude participants less than 2 years old. • Studies that do not specify the amount of total digestible carbohydrate intake (e.g., studies that only report type or source of digestible carbohydrate). • Studies that do not describe the entire macronutrient distribution of the diet (i.e., studies that do not report total digestible carbohydrate, total fat, and total protein contents of experimental or baseline diets). • Studies that only assess digestible carbohydrate intake via infusions (rather than the GI tract). • Studies that primarily measure postprandial responses, as opposed to longer term studies. • Studies that examine food products or dietary supplements not widely available to U.S. consumers. • Multi-component interventions that do not isolate the effect or association of digestible carbohydrate. • Comparison of different sources of carbohydrates without specifying the amount of carbohydrate intake. • Studies that do not attempt to control for the energy intake of participants such that comparisons are made on an isocaloric basis. • Comparisons of available carbohydrate exposure should not be confounded by differences in participants’ energy intake. • Type 1 Diabetes. VerDate Sep<11>2014 18:57 Jan 12, 2024 Jkt 262001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\16JAN1.SGM 16JAN1 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2611 INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)—Continued PICOTS elements Inclusion criteria Timing ............... • Type 2 diabetes ................................................ • Minimum intervention length of 12 weeks Effect on growth, size, and body composition. Æ Minimum intervention length of 12 weeks. • All except hospital and acute care .................... • Randomized controlled trials ............................. • Nonrandomized controlled trials, including quasi-experimental and controlled before-andafter studies. • Prospective cohort studies ................................ • Nested case-control studies .............................. • Relevant systematic reviews, or meta-analyses (used for identifying additional studies). • Studies published in English only ..................... • Studies published in peer-reviewed journals .... • Studies published at and after the year 2000 .. Settings ............. Study design ..... Publications ....... Exclusion criteria • Any intervention length <12 weeks. • Hospital and acute care. • In vitro studies, nonoriginal data (e.g., narrative reviews, scoping reviews, editorials, letters, or erratum), retrospective cohort studies, case series, qualitative studies, cost-benefit analysis, cross-sectional (i.e., nonlongitudinal) studies, survey. • Non-English language studies. Abbreviations: BMI = body mass index; HbA1c = hemoglobin A1C; GI = gastrointestinal; KQ = Key Question; PICOTS = populations, interventions, comparators, outcomes, timing, and settings; RCT = randomized controlled trial; U.S. = United States Dated: January 8, 2024. Marquita Cullom, Associate Director. [FR Doc. 2024–00618 Filed 1–12–24; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Updating the Measurement Criteria for AHRQ’s National Healthcare Quality and Disparities Report (NHQDR) Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submission. SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Updating the Measurement Criteria for AHRQ’s National Healthcare Quality and Disparities Report (NHQDR), which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before February 15, 2024. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. Print submissions: Mailing Address: Center for Evidence and Practice Improvement, Agency for ddrumheller on DSK120RN23PROD with NOTICES1 AGENCY: VerDate Sep<11>2014 18:57 Jan 12, 2024 Jkt 262001 Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301–427–1656 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Updating the Measurement Criteria for AHRQ’s National Healthcare Quality and Disparities Report (NHQDR). AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a. The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Updating the Measurement Criteria for AHRQ’s National Healthcare Quality and Disparities Report (NHQDR). The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/ products/measurement-criteria-qdr/ protocol. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 This is to notify the public that the EPC Program would find the following information on Updating the Measurement Criteria for AHRQ’s National Healthcare Quality and Disparities Report (NHQDR) helpful: D A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. D For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to follow-up/withdrawn/ analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Pages 2609-2611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00618]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on The Effect of Dietary 
Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, 
Size, and Body Composition

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submission.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on The Effect of 
Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, 
Growth, Size, and Body Composition, which is currently being conducted 
by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before February 15, 2024.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for The Effect of Dietary 
Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, 
Size, and Body Composition. AHRQ is conducting this review pursuant to 
Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on The Effect of Dietary Digestible Carbohydrate Intake on 
Risk of Type 2 Diabetes, Growth, Size, and Body Composition. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/effect-dietary-digestible.
    This is to notify the public that the EPC Program would find the 
following information on The Effect of Dietary Digestible Carbohydrate 
Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition 
helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this topic. In the list, please indicate whether results 
are available on ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements, if 
relevant: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this topic. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including, if relevant, a study number, the 
study period, design,

[[Page 2610]]

methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this topic and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on topics not included 
in the review cannot be used by the EPC Program. This is a voluntary 
request for information, and all costs for complying with this request 
must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The review will answer the following questions. This information is 
provided as background. AHRQ is not requesting that the public provide 
answers to these questions.

Key Questions (KQ)

    KQ 1: What is the association between dietary digestible 
carbohydrate intake and the incidence of type 2 diabetes (T2D) and 
effect on growth, size, and body composition (i.e., obesity, 
overweight, body weight and composition)?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and 
Setting)

      Inclusion and Exclusion Criteria by Population, Intervention,
       Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
------------------------------------------------------------------------
      PICOTS elements         Inclusion criteria     Exclusion criteria
------------------------------------------------------------------------
Population................   Participants   Studies that
                             who are generally      enroll participants
                             healthy, including     with diseases/health-
                             participants who are   related conditions
                             determined to be       that impact
                             overweight/obese,      carbohydrate
                             women who are          absorption or
                             pregnant or            metabolism including
                             lactating.             cancer and
                             Age of         malabsorption
                             participants:.         syndromes.
                            [cir] Between 2 and 9   Studies that
                             years (before          exclusively enroll
                             puberty).              participants
                            [cir] Between 9 and     hospitalized with an
                             17 years.              illness or injury.
                            [cir] 18 years and      Studies that
                             older..                exclusively enroll
                                                    participants with
                                                    type 1 or 2 diabetes
                                                    (i.e., studies that
                                                    aim to treat
                                                    participants who
                                                    have already been
                                                    diagnosed with the
                                                    endpoint outcomes of
                                                    interest).
                                                    Studies
                                                    designed to induce
                                                    weight loss or treat
                                                    patients who are
                                                    determined to be
                                                    overweight and obese
                                                    through energy
                                                    restriction or
                                                    hypocaloric diets
                                                    for the purposes of
                                                    treating additional
                                                    or other medical
                                                    conditions.
                                                    Studies that
                                                    exclusively enroll
                                                    participants who are
                                                    determined to be
                                                    undernourished,
                                                    underweight,
                                                    stunted, or wasted.
                                                    Studies that
                                                    enroll participants
                                                    who are prebariatric
                                                    or postbariatric
                                                    surgery.
                                                    Exclude
                                                    participants less
                                                    than 2 years old.
Interventions.............   Total          Studies that
                             dietary digestible     do not specify the
                             carbohydrate intake    amount of total
                             from foods,            digestible
                             beverages, and         carbohydrate intake
                             dietary supplements.   (e.g., studies that
                            [cir] Total dietary     only report type or
                             digestible             source of digestible
                             carbohydrate intake    carbohydrate).
                             defined as             Studies that
                             collective starch      do not describe the
                             and sugar intake;      entire macronutrient
                             carbohydrate intake    distribution of the
                             not including          diet (i.e., studies
                             dietary fiber).        that do not report
                             A dietary      total digestible
                             pattern that           carbohydrate, total
                             quantifies the         fat, and total
                             intake of total        protein contents of
                             dietary digestible     experimental or
                             carbohydrates and      baseline diets).
                             allows the isolation   Studies that
                             of the effect of       only assess
                             carbohydrate intake    digestible
                             from the effect of     carbohydrate intake
                             the intake of other    via infusions
                             macronutrients.        (rather than the GI
                                                    tract).
                                                    Studies that
                                                    primarily measure
                                                    postprandial
                                                    responses, as
                                                    opposed to longer
                                                    term studies.
                                                    Studies that
                                                    examine food
                                                    products or dietary
                                                    supplements not
                                                    widely available to
                                                    U.S. consumers.
                                                    Multi-
                                                    component
                                                    interventions that
                                                    do not isolate the
                                                    effect or
                                                    association of
                                                    digestible
                                                    carbohydrate.
Comparators...............   Different      Comparison
                             total dietary          of different sources
                             digestible             of carbohydrates
                             carbohydrate intake    without specifying
                             level(s).              the amount of
                                                    carbohydrate intake.
                                                    Studies that
                                                    do not attempt to
                                                    control for the
                                                    energy intake of
                                                    participants such
                                                    that comparisons are
                                                    made on an
                                                    isocaloric basis.
                                                    Comparisons
                                                    of available
                                                    carbohydrate
                                                    exposure should not
                                                    be confounded by
                                                    differences in
                                                    participants' energy
                                                    intake.
Outcomes..................   Incidence of   Type 1
                             type 2 diabetes.       Diabetes.
                             Incidence of
                             gestational diabetes.
                             Surrogate
                             markers suggesting
                             prediabetes or
                             abnormal glycemia.
                               [cir] HbA1C level.
                               [cir] Glucose
                                tolerance/insulin
                                resistance/
                                insulin
                                sensitivity.
                             Growth,
                             size, and body
                             composition.
                               [cir] Body weight.
                               [cir] BMI.........
                               [cir] Body
                                circumference.
                               [cir] Body
                                composition and
                                distribution.
                               [cir]
                                Classifications
                                of underweight,
                                healthy weight,
                                overweight, and
                                obesity.

[[Page 2611]]

 
Timing....................   Type 2         Any
                             diabetes.              intervention length
                                                    <12 weeks.
                             Minimum
                             intervention length
                             of 12 weeks Effect
                             on growth, size, and
                             body composition.
                               [cir] Minimum
                                intervention
                                length of 12
                                weeks.
Settings..................   All except     Hospital and
                             hospital and acute     acute care.
                             care.
Study design..............   Randomized     In vitro
                             controlled trials.     studies, nonoriginal
                                            data (e.g.,
                             Nonrandomized          narrative reviews,
                             controlled trials,     scoping reviews,
                             including quasi-       editorials, letters,
                             experimental and       or erratum),
                             controlled before-     retrospective cohort
                             and-after studies.     studies, case
                             Prospective    series, qualitative
                             cohort studies.        studies, cost-
                             Nested case-   benefit analysis,
                             control studies.       cross-sectional
                             Relevant       (i.e.,
                             systematic reviews,    nonlongitudinal)
                             or meta-analyses       studies, survey.
                             (used for
                             identifying
                             additional studies).
Publications..............   Studies        Non-English
                             published in English   language studies.
                             only.
                             Studies
                             published in peer-
                             reviewed journals.
                             Studies
                             published at and
                             after the year 2000.
------------------------------------------------------------------------
Abbreviations: BMI = body mass index; HbA1c = hemoglobin A1C; GI =
  gastrointestinal; KQ = Key Question; PICOTS = populations,
  interventions, comparators, outcomes, timing, and settings; RCT =
  randomized controlled trial; U.S. = United States


    Dated: January 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-00618 Filed 1-12-24; 8:45 am]
BILLING CODE 4160-90-P


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