Overview

This trial is active, not recruiting.

Conditions obesity, weight loss
Treatment weight loss group (full meal replacement products)
Sponsor Beth Israel Deaconess Medical Center
Start date September 2012
End date November 2017
Trial size 30 participants
Trial identifier NCT01780870, 2011P-000293

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(No Intervention)
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
(Active Comparator)
Full Meal replacement Protocol
weight loss group (full meal replacement products) Full meal replacement products (1280-1320 kcal/day)
In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase

Primary Outcomes

Measure
The primary outcome will be the difference in insulin and leptin tolerance after weight loss
time frame: 8 weeks (10 ± 2% body weight reduction)

Secondary Outcomes

Measure
Difference in brain signaling before and after the 10 ± 2% body weight reduction.
time frame: 8 weeks (10 ± 2% body weight reduction)

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Principal investigator Christos Mantzoros, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.