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OpenTrials
Completed

NCT Number: NCT00415688

Lifestyle Modification for Obesity-Related Type 2 Diabetes

Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Health System

Durham, North Carolina, 27704, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes mellitus for at least one year
  • hgba1c > 6.0
  • BMI from 27-50 kg/m2

Exclusion criteria

  • Unstable medical condition
  • Serious medical condition
  • AST or ALT > 100
  • Serum creatinine > 1.5

Treatment and study plan

Low carbohydrate, ketogenic diet

Behavioral

Low glycemic index, reduced calorie diet

Behavioral

Primary outcomes

  1. Hemoglobin A1c

Secondary outcomes

  1. Body weight

  2. Serum lipoproteins

Sponsors and collaborators

Lead sponsor

Robert C. Atkins Foundation

Other

Registry information

Official study title

A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes

Important dates

Study start
2004
Study completion
2006
First posted
Dec 25, 2006
Registry last updated
Dec 25, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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