Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes
- Diet Modification
- Endocrine System Diseases
- Glucose Intolerance
- Glucose Metabolism Disorders (Including Diabetes Mellitus)
- Hyperglycemia
- Metabolic Disease
- Prediabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 40 years and 70 years
- Gender
- Both males and females
Description
In the short-term, among patients with type 2 diabetes, low-to-moderate carbohydrate diets have a greater glucose-lowering effect than do high-carbohydrate diets. However, compared with usual diet, the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-pro...
In the short-term, among patients with type 2 diabetes, low-to-moderate carbohydrate diets have a greater glucose-lowering effect than do high-carbohydrate diets. However, compared with usual diet, the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern among individuals with prediabetes or untreated type 2 diabetes is not well understood. The overall goal of this randomized controlled trial is to study the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern compared with usual diet on hemoglobin A1c (HbA1c) and other metabolic risk factors among individuals with or at high risk of diabetes (HbA1c 6.0-6.9%). A total of 150 participants with HbA1c 6.0-6.9% will be recruited and randomly assigned to either a 6-month behavioral modification program designed to reduce carbohydrate intake (initial target <40 g digestible carbohydrates, final target <60 g digestible carbohydrates) or to usual diet in a 1:1 randomization ratio. The primary outcome will be the difference between the active intervention and control groups for change in HbA1c from baseline to 6 months. Secondary outcomes will be fasting glucose, systolic blood pressure, total-to-high-density lipoprotein-cholesterol ratio, and body weight. Findings from this study may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.
Tracking Information
- NCT #
- NCT03675360
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Investigators
- Principal Investigator: Kirsten Dorans, ScD Tulane University School of Public Health and Tropical Medicine