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

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

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

Conditions
-----------------
Obesity, Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Weight loss group (Full meal replacement products)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy | |
| Active Comparator: Weight loss group<br>Full Meal replacement Protocol | Dietary Supplement: Weight loss group (Full meal replacement products)<br>* 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<br>* Other names: Full meal replacement products (1280-1320 kcal/day);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks | The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment | 8 weeks | 
| The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks | The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment | 8 weeks | 
| The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks | The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Obese, Weight loss