An interventional study of Weight loss group (Full meal replacement products) in Obesity and Weight Loss, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-07.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Basic science
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:
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for interventional group:
Inclusion Criteria for control group:
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Full Meal replacement Protocol
Dietary Supplement: 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
Also known as: Full meal replacement products (1280-1320 kcal/day)
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
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
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
| Milestone | Control Group | Weight Loss Group |
|---|---|---|
| Started | 0 | 5 |
| Completed | 0 | 5 |
| Not completed | 0 | 0 |
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
| ng/ml | Control Group | Weight Loss Group |
|---|---|---|
| Baseline Leptin | — | 39.5 ± 7.7 |
| Week 8 Leptin | — | 13.4 ± 1.6 |
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
| μU/ml | Control Group | Weight Loss Group |
|---|---|---|
| Baseline Insulin | — | 13 ± 1.6 |
| Week 8 Insulin | — | 6.4 ± 1.4 |
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
| HOMA score | Control Group | Weight Loss Group |
|---|---|---|
| Baseline HOMA-IR | — | 2.82 ± 0.37 |
| Week 8 HOMA-IR | — | 1.33 ± 0.31 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | — | — |
| Weight Loss Group | — | 0/5 (0%) | 0/5 (0%) |
Due to enrolling problems, no subjects were enrolled to the control group. All the subjects were enrolled to the weight loss group
| Age, Categorical(Participants) | Control Group | Weight Loss Group | Total |
|---|---|---|---|
| <=18 years | — | 0 | 0 |
| Between 18 and 65 years | — | 5 | 5 |
| >=65 years | — | 0 | 0 |
| Age, Continuous(years) | Control Group | Weight Loss Group | Total |
|---|---|---|---|
| Mean | — | 32.8 ± 3.1 | 32.8 ± 3.1 |
| Sex: Female, Male(Participants) | Control Group | Weight Loss Group | Total |
|---|---|---|---|
| Female | — | 5 | 5 |
| Male | — | 0 | 0 |
| Region of Enrollment(participants) | Control Group | Weight Loss Group | Total |
|---|---|---|---|
| United States | — | 5 | 5 |
Plan to share: No
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center