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Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial

NCT03675360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-03-01

Study results available
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Summary

The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.

Conditions

  • Diabetes
  • PreDiabetes
  • Metabolic Disease
  • Hyperglycemia
  • Diet Modification
  • Glucose Intolerance
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)
  • Endocrine System Diseases

Interventions

BEHAVIORAL

Low-Carbohydrate Diet

Behavioral modification to reduce carbohydrate consumption. Target \<40 g net carbohydrates per day for first 3 months; \<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Tulane University School of Public Health and Tropical Medicine

    lead OTHER

Principal Investigators

  • Kirsten Dorans, ScD · Tulane University School of Public Health and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2021-06-21
Completion
2021-06-21

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675360 on ClinicalTrials.gov