Leptin in the Maintenance of Reduced Body Weight
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity
In brief
You are invited to take part in a research study about the role of leptin (a fat cell hormone that normally circulates in the blood) on maintaining a reduced body weight. This study will also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used at rest), autonomic nervous function (the part of your brain that controls your heart rate and breathing), changes in body composition and your sense of appetite. Under normal conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and regulate energy usage and hormone levels. When obese individuals lose weight, their leptin levels go down, which may cause them to later regain the weight. This study will provide leptin as an investigational medication (not yet approved by the Food and Drug Administration) to increase the levels of the leptin hormone that normally circulates in your blood back to a normal range. We will see if this can help you to maintain your reduced body weight and improve your hormonal and metabolic function.
Key facts
- Study ID
- NCT01155180
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 24
- Starts
- 2008-07-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-04-07
Who can join
Age: 18 and older, up to 67. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Any condition that would exclude a patient from lap band surgery as listed below -
- patients with untreated major depression or psychosis
- binge eating disorders
- current drug and alcohol abuse
- severe cardiac disease with prohibitive anesthetic risks
- severe coagulopathy i
- inability to comply with nutritional requirements including life-long vitamin replacement.
- pregnancy
- Any additional condition which is not in accordance with standard of care as per Bariatric Clinic at BIDMC.
- Any condition which in the opinion of the investigators makes the candidate unsuitable for participation in this study
- Diabetes controlled by medication
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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