Progressive Weight Loss and Metabolic Health (PWL)

The Washington University

Status: Completed

Conditions: Insulin Resistance; Obesity

Treatments: Behavioral: Weight Loss; Behavioral: Weight Maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT01299519

201012904

Details and patient eligibility

About

This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%) weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes. Participants will be randomly assigned to one of 2 groups. Group 1: supervised weight loss group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet). Of those assigned to group 1, half of the participants will lose 5% of their body weight and the other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a dietitian. Research testing will be repeated at each time point (5%, 10%, and 15% weight loss). In group 2, research testing will be repeated after six months.

Enrollment: 59 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese: Body Mass Index from 30 to 45
• Insulin Resistant: HOMA-IR score greater than or equal to 2

Exclusion criteria

• diabetes
• smoking
• pregnancy
• breastfeeding
• heart failure
• history of liver disease including hepatitis
• alcoholism
• exercise more than 2 hours per week

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Weight Loss

Experimental group

Description:

Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.

Treatment:

Behavioral: Weight Loss

Weight Maintenance

Active Comparator group

Description:

Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.

Treatment:

Behavioral: Weight Maintenance