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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Published in: Trials 1/2021

Open Access 01-12-2021 | Prediabetes | Study protocol

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

Authors: Kirsten S. Dorans, Lydia A. Bazzano, Lu Qi, Hua He, Lawrence J. Appel, Jonathan M. Samet, Jing Chen, Katherine T. Mills, Bernadette T. Nguyen, Matthew J. O’Brien, Gabriel I. Uwaifo, Jiang He

Published in: Trials | Issue 1/2021

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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).
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Metadata
Title
Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial
Authors
Kirsten S. Dorans
Lydia A. Bazzano
Lu Qi
Hua He
Lawrence J. Appel
Jonathan M. Samet
Jing Chen
Katherine T. Mills
Bernadette T. Nguyen
Matthew J. O’Brien
Gabriel I. Uwaifo
Jiang He
Publication date
01-12-2021
Publisher
BioMed Central
Keyword
Prediabetes
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-05001-x

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