Leptin in the Maintenance of Reduced Body Weight

Obesity Clinical Trial

Official title:

Leptin in the Maintenance of Reduced Body Weight

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01155180
• Other study ID #: 2008-P000190
• Secondary ID: R01DK079929
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 16, 2010
• Last updated: December 17, 2015
• Start date: July 2008
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Drug:
• Leptin
Hormone - daily self injections for 6 months
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		6 months after randomization	No