Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss

Beth Israel Lahey Health

Status: Completed

Conditions: Weight Loss; Obesity

Treatments: Dietary Supplement: Weight loss group (Full meal replacement products)

Study type: Interventional

Funder types: Other

Identifiers

NCT01780870

2011P000293

Details and patient eligibility

About

The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.

The investigators will also study the following:

1. The impact of diet induced weight loss on hormones/adipokine levels
2. The impact of diet induced weight loss on leptin tolerance

Enrollment: 5 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for interventional group:

1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
4. Willing to enroll in a low calorie full meal replacement weight loss program
5. Willing and able to take part in a multi year study involving visits

Inclusion Criteria for control group:

1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
4. Willing and able to take part in a multi year study involving visits

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Control Group

No Intervention group

Description:

Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy

Weight loss group

Active Comparator group

Description:

Full Meal replacement Protocol

Treatment:

Dietary Supplement: Weight loss group (Full meal replacement products)