Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy | |
| Weight loss group | Active Comparator | Full Meal replacement Protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss group (Full meal replacement products) | Dietary Supplement | 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria for interventional group:
Inclusion Criteria for control group:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christos Mantzoros, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy |
| FG001 | Weight Loss Group | Full Meal replacement Protocol Weight loss group (Full meal replacement products): 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to enrolling problems, no subjects were enrolled to the control group. All the subjects were enrolled to the weight loss group
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy |
| BG001 | Weight Loss Group | Full Meal replacement Protocol Weight loss group (Full meal replacement products): 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ng/ml | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christos Mantzoros | Beth Israel Deaconess Medical Center | 6176678633 | cmantzor@bidmc.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | μU/ml | 8 weeks |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | HOMA score | 8 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Weight Loss Group | Full Meal replacement Protocol Weight loss group (Full meal replacement products): 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 | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |