N/A
N=5
Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Obesity · Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT01780870 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks — 39.5; 13.4 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weight loss group (Full meal replacement products) (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks |
39.5; 13.4 | — |
| PRIMARY The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks |
13; 6.4 | — |
| PRIMARY The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks |
2.82; 1.33 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01780870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.