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Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial.

Trials
January 1, 1970
Kirsten S Dorans et al. (12 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine the effect of a healthy low-carbohydrate diet on HbA1c and other metabolic risk factors in individuals with elevated HbA1c (6.0-6.9%) not on glucose-lowering medications.

Results Summary

The study expects the low-carbohydrate diet to reduce HbA1c and improve metabolic risk factors, with potential applicability in clinical practice for reducing cardiometabolic disease risk.

Population

Individuals with HbA1c levels of 6.0-6.9% not currently on glucose-lowering medications.

Effective Dosage

<40g net carbohydrates for the first 3 months, <40-60g net carbohydrates for months 3-6.

Duration

6 months

Interactions

None mentioned

Extracted Claims (14)
InterventionDirectionEndpointPopulationDosageImpactClaim #
low-carbohydrate diets
decrease
hemoglobin A1c (HbA1c)
individuals with T2DM
-
lead to decreases
#1
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
HbA1c
individuals with HbA1c from 6.0 to 6.9% who are not on glucose-lowering medications
-
effect
#2
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
other metabolic risk factors
individuals with HbA1c from 6.0 to 6.9% who are not on glucose-lowering medications
-
effect
#3
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
HbA1c
participants
-
difference in change
#4
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
fasting glucose
participants
-
differences between groups in 6-month changes
#5
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
systolic blood pressure
participants
-
differences between groups in 6-month changes
#6
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
total-to-high-density lipoprotein (HDL) cholesterol ratio
participants
-
differences between groups in 6-month changes
#7
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
body weight
participants
-
differences between groups in 6-month changes
#8
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
fasting insulin
participants
-
differences in 6-month changes
#9
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
homeostasis model assessment of insulin resistance
participants
-
differences in 6-month changes
#10
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
diastolic blood pressure
participants
-
differences in 6-month changes
#11
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
waist circumference
participants
-
differences in 6-month changes
#12
healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation
neutral
10-year cardiovascular disease risk
participants
-
differences in 6-month changes
#13
dietary approaches (other than the most commonly used reduced fat diet)
decrease
cardiometabolic disease
adults with or at high risk of T2DM
-
substantially reduce risk
#14
Abstract

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM, low-carbohydrate diets lead to decreases in hemoglobin A1c (HbA1c). However, research on the effects of low-carbohydrate diets on glycemic outcomes among individuals not currently on glucose-lowering medications who have elevated HbA1c is limited. METHODS: The objective of this randomized controlled trial is to study the effect of a healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation compared with usual diet on HbA1c and other metabolic risk factors among individuals with HbA1c from 6.0 to 6.9% who are not on glucose-lowering medications. In this parallel trial, 150 participants will be randomized to the intervention or control group for 6 months. The healthy low-carbohydrate diet target is < 40 g of net carbohydrates during the first 3 months and < 40 to 60 net grams for months 3 to 6. This diet is characterized by abundant unsaturated fat and protein, high-fiber foods such as non-starchy vegetables and nuts, and minimal refined carbohydrates. The primary outcome is the difference in HbA1c change from baseline to 6 months in the intervention compared with usual diet group. Secondary outcomes include differences between groups in 6-month changes in fasting glucose, systolic blood pressure, total-to-high-density lipoprotein (HDL) cholesterol ratio, and body weight. Exploratory outcomes include differences in 6-month changes in fasting insulin, homeostasis model assessment of insulin resistance, diastolic blood pressure, waist circumference, and 10-year cardiovascular disease risk. An intention-to-treat analysis will be used. DISCUSSION: We expect that the results from this study will lead to new approaches for developing and implementing dietary approaches (other than the most commonly used reduced fat diet) that will substantially reduce risk of cardiometabolic disease among adults with or at high risk of T2DM. The study intervention involves behavioral counseling and promotes consumption of dietary components thought to reduce risk of cardiometabolic disease and has expected applicability in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03675360 . Registered on September 18, 2018 (prior to enrolment of the first participant).

Medical Subject Headings (MeSH)
AdultBlood GlucoseBody WeightDiabetes Mellitus, Type 2Diet, Carbohydrate-RestrictedGlycated HemoglobinHumansRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations2
Citations/Year0.5
Relative Citation Ratio0.20
NIH Percentile10.2%
Research Impact Scores
APT Score0.50
Weight Score1.54
Normalized Score0.67
Related Supplements
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