Status:
COMPLETED
Leptin in the Maintenance of Reduced Body Weight
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-67 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Study Overview This study is a randomized, double-blind, placebo-controlled study of leptin administration to individuals with a recent 10% weight loss, achieved through lifestyle intervention program...
Eligibility Criteria
Inclusion
- Inclusion criteria for dietary induced weight loss group:
- Age 18 or older
- Body mass index (pre weight loss) between 30 and 40 kg/m2.
- Weight loss achieved over a period not greater than 6 months.
- Exclusion criteria for dietary induced weight loss group:
- Use of a very low calorie diet in the year prior to the start of the study
- History of diabetes
- History of any illness that may affect the concentrations of the hormones to be studied (such as anemia, infectious diseases, renal or hepatic failure, cancer, lymphoma, clinically evident hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)
- On medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti seizure medications or thyroid hormones), or medications for weight loss.
- Known history of reactions or known hypersensitivity to E. Coli derived proteins
- Breast feeding, pregnant, or wanting to become pregnant during the next year
- Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.).
- Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- Subjects that exhibit noticeable anxiety and/or claustrophobia.
- Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
- Subjects who have significant sensory or motor impairment; - Subjects who suffer from epilepsy, in particular photo-sensitive epilepsy (this would be a risk for scanning with visual stimulation).
- Subjects with neurological problems that might interfere or complicate testing (e.g. presence of titubation).
- Subjects who cannot adhere to the experimental protocol for any reason.
- Inclusion criteria for lap band surgery induced weight loss group:
- Age 18 or older.
- Body mass index (pre weight loss) between 30 and 40 kg/m2.
- Weight loss achieved over a period not greater than 6 months.
- Approved for bariatric surgery as per Beth Israel Deaconess Medical Center (BIDMC) Bariatric Clinic guidelines
- Adult men and women, age 18-65
- English speaking
- Willing and able to take part in a multi year study involving visits and telephone interviews
- Enrolled prior to bariatric surgery.
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01155180
Start Date
July 1 2008
End Date
December 1 2016
Last Update
April 7 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215