Obesity, Weight Loss
Conditions
Keywords
Overweight, Obesity, Obese, Weight loss
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: 1. The impact of diet induced weight loss on hormones/adipokine levels 2. The impact of diet induced weight loss on leptin tolerance
Interventions
DIETARY_SUPPLEMENTWeight 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
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks | 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 | 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 | 8 weeks | The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy | 0 |
| 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Total | Weight Loss Group |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants |
| Age, Continuous | 32.8 years STANDARD_DEVIATION 3.1 | 32.8 years STANDARD_DEVIATION 3.1 |
| Region of Enrollment United States | 5 participants | 5 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 5 |
| serious Total, serious adverse events | 0 / 0 | 0 / 5 |
Outcome results
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
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss Group | The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks | Baseline HOMA-IR | 2.82 HOMA score | Standard Deviation 0.37 |
| Weight Loss Group | The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks | Week 8 HOMA-IR | 1.33 HOMA score | Standard Deviation 0.31 |
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
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss Group | The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks | Baseline Insulin | 13 μU/ml | Standard Deviation 1.6 |
| Weight Loss Group | The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks | Week 8 Insulin | 6.4 μU/ml | Standard Deviation 1.4 |
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
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weight Loss Group | The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks | Baseline Leptin | 39.5 ng/ml | Standard Deviation 7.7 |
| Weight Loss Group | The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks | Week 8 Leptin | 13.4 ng/ml | Standard Deviation 1.6 |