A Trial of Two Diets for Weight and Diabetes Management (Two-for-2)

National Institutes of Health (NIH)

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Behavioral: Lifestyle Modification

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00729196

K23DK070777 (U.S. NIH Grant/Contract)

K23 DK70777 (completed)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

Low-Glycemic Load Diet

Treatment:

Behavioral: Lifestyle Modification

2

Active Comparator group

Description:

Low-Fat Diet

Treatment:

Behavioral: Lifestyle Modification