Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
Study Overview
Brief 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:
- The impact of diet induced weight loss on hormones/adipokine levels
- The impact of diet induced weight loss on leptin tolerance
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for interventional group:
- •Adult men and women, age 18-50
- •English speaking
- •Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- •Willing to enroll in a low calorie full meal replacement weight loss program
- •Willing and able to take part in a multi year study involving visits
- •Inclusion Criteria for control group:
- •Adult men and women, age 18-50
- •English speaking
- •Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- •Willing and able to take part in a multi year study involving visits
Exclusion Criteria
- Not provided
Arms & Interventions
Control Group
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Weight loss group
Full Meal replacement Protocol
Intervention: Weight loss group (Full meal replacement products) (Dietary Supplement)
Outcomes
Primary Outcomes
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
Time Frame: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks
Time Frame: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks
Time Frame: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Secondary Outcomes
No secondary outcomes reported
Investigators
Christos Mantzoros
Professor of Medicine
Beth Israel Deaconess Medical Center