A Trial of Two Diets for Weight and Diabetes Management

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.

Detailed Description
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This research is a randomized controlled trial to compare long-term outcomes behavioral weight loss interventions that include either low-fat or low-glycemic load dietary instruction. Targets for energy intake and expenditure, and behavioral skills taught, are identical across the two diets. Additionally, both treatments include 20 weekly group sessions, followed by 10 every-other-week sessions. Participants are overweight and obese adults with type 2 diabetes. The primary outcomes are changes in weight and glycated hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater weight losses and maintain better glycemic control at the end of treatment (i.e., week 40) and after 1 year of no-treatment follow-up (i.e., week 92).

Official Title
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A Trial of Two Diets for Weight and Diabetes Management

Conditions
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Type 2 Diabetes Mellitus, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes Mellitus Body mass index (BMI) of 27 to 45 kg/m2 with weight </= 136 kg (300 lbs. Capacity to provide written informed consent Systolic blood pressure between 90 and 160 mm Hg, inclusive. Diastolic blood pressure between 65 and 100 mm Hg, inclusive. Resting heart rate between 65 and 90 beats per minute, inclusive. Exclusion Criteria: a recent (i.e., within 1 year) myocardial infarction unstable angina malignant arrhythmias history of cerebrovascular, renal, or hepatic disease history of seizures protein wasting diseases (e.g., Cushing's syndrome) uncontrolled hypertension (> 160/100 mm Hg) type 1 diabetes uncontrolled thyroid disease pregnancy or lactation electrolyte abnormalities clinically significant psychosocial impairment (principally, major depression) treatment with steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low-Glycemic Load Diet | Behavioral: Lifestyle Modification<br>* Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks<br>|
| Active Comparator: 2<br>Low-Fat Diet | Behavioral: Lifestyle Modification<br>* Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in weight |  | 92 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 92 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Type 2 Diabetes, Glycemic Load, Weight Loss, Glycated Hemoglobin