[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]


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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.

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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published and unpublished pertinent scientific information will improve 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: <a href="/cdn-cgi/l/email-protection#94f1e4f7d4f5fce6e5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="0366736043626b71722d6b6b702d646c75">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#abcedbc8ebcac3d9da85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="a5c0d5c6e5c4cdd7d48bcdcdd68bc2cad3">[email protected]</span></a>.

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................  <bullet> Participants  <bullet> 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
                            <bullet> Age of         malabsorption
                             participants:.         syndromes.
                            [cir] Between 2 and 9  <bullet> Studies that
                             years (before          exclusively enroll
                             puberty).              participants
                            [cir] Between 9 and     hospitalized with an
                             17 years.              illness or injury.
                            [cir] 18 years and     <bullet> 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).
                                                   <bullet> 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.
                                                   <bullet> Studies that
                                                    exclusively enroll
                                                    participants who are
                                                    determined to be
                                                    undernourished,
                                                    underweight,
                                                    stunted, or wasted.
                                                   <bullet> Studies that
                                                    enroll participants
                                                    who are prebariatric
                                                    or postbariatric
                                                    surgery.
                                                   <bullet> Exclude
                                                    participants less
                                                    than 2 years old.
Interventions.............  <bullet> Total         <bullet> 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            <bullet> 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
                            <bullet> 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  <bullet> 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).
                                                   <bullet> Studies that
                                                    primarily measure
                                                    postprandial
                                                    responses, as
                                                    opposed to longer
                                                    term studies.
                                                   <bullet> Studies that
                                                    examine food
                                                    products or dietary
                                                    supplements not
                                                    widely available to
                                                    U.S. consumers.
                                                   <bullet> Multi-
                                                    component
                                                    interventions that
                                                    do not isolate the
                                                    effect or
                                                    association of
                                                    digestible
                                                    carbohydrate.
Comparators...............  <bullet> Different     <bullet> Comparison
                             total dietary          of different sources
                             digestible             of carbohydrates
                             carbohydrate intake    without specifying
                             level(s).              the amount of
                                                    carbohydrate intake.
                                                   <bullet> Studies that
                                                    do not attempt to
                                                    control for the
                                                    energy intake of
                                                    participants such
                                                    that comparisons are
                                                    made on an
                                                    isocaloric basis.
                                                   <bullet> Comparisons
                                                    of available
                                                    carbohydrate
                                                    exposure should not
                                                    be confounded by
                                                    differences in
                                                    participants' energy
                                                    intake.
Outcomes..................  <bullet> Incidence of  <bullet> Type 1
                             type 2 diabetes.       Diabetes.
                            <bullet> Incidence of
                             gestational diabetes.
                            <bullet> Surrogate
                             markers suggesting
                             prediabetes or
                             abnormal glycemia.
                               [cir] HbA1C level.
                               [cir] Glucose
                                tolerance/insulin
                                resistance/
                                insulin
                                sensitivity.
                            <bullet> 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....................  <bullet> Type 2        <bullet> Any
                             diabetes.              intervention length
                                                    <12 weeks.
                            <bullet> Minimum
                             intervention length
                             of 12 weeks Effect
                             on growth, size, and
                             body composition.
                               [cir] Minimum
                                intervention
                                length of 12
                                weeks.
Settings..................  <bullet> All except    <bullet> Hospital and
                             hospital and acute     acute care.
                             care.
Study design..............  <bullet> Randomized    <bullet> In vitro
                             controlled trials.     studies, nonoriginal
                            <bullet>                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
                            <bullet> Prospective    series, qualitative
                             cohort studies.        studies, cost-
                            <bullet> Nested case-   benefit analysis,
                             control studies.       cross-sectional
                            <bullet> Relevant       (i.e.,
                             systematic reviews,    nonlongitudinal)
                             or meta-analyses       studies, survey.
                             (used for
                             identifying
                             additional studies).
Publications..............  <bullet> Studies       <bullet> Non-English
                             published in English   language studies.
                             only.
                            <bullet> Studies
                             published in peer-
                             reviewed journals.
                            <bullet> 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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