Notice2024-00618
Supplemental Evidence and Data Request on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Type 2 Diabetes, Growth, Size, and Body Composition
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 16, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 10 (Tuesday, January 16, 2024)</title>
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[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Pages 2609-2611]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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published and unpublished pertinent scientific information will improve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: <a href="https://effectivehealthcare.ahrq.gov/products/effect-dietary-digestible">https://effectivehealthcare.ahrq.gov/products/effect-dietary-digestible</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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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