Short-term Effects of Leptin in People With Lipodystrophy
Completed · Phase 2
Conditions studied: Lipodystrophy
In brief
Background: \- Lipodystrophy is a condition where people do not have enough fat in the body. People with lipodystrophy can have problems such as diabetes or an enlarged liver. Researchers are looking at how leptin, a hormone produced by fat cells, can help people with these problems. Leptin helps control appetite and how the body stores food. Taking leptin can help people with lipodystrophy eat less food, which may help treat diabetes and other problems. To better understand how leptin works, researchers want to do an inpatient study on leptin treatment in people with lipodystrophy. Objectives: \- To study how leptin treatment affects lipodystrophy. Eligibility: \- Individuals between 14 and 70 years of age who have lipodystrophy. Design: * All participants will have a 19-day stay at the National Institutes of Health Clinical Center. One group of participants will have tests for 5 days before starting to take leptin. They will then take leptin for 2 weeks, and have more tests. The other group of participants will have tests for 5 days while taking leptin. They will then take stop taking leptin for 2 weeks, and have more tests, and then they will start taking leptin again. * Participants will have regular blood and urine tests during the visit. Some of the blood tests will look at insulin levels. Some will look at how the body metabolizes sugar and fat. Other tests will check hormone levels, especially of reproductive hormones. * During the visit, participants will spend 3 separate days in a metabolic chamber, a special room that measures how many calories the body uses. Urine samples will be collected during these stays. * Participants will also have several body imaging studies, including magnetic resonance imaging and a body composition scan. * Physical activity will be tested with an exercise bicycle and an electronic activity monitor. * Participants will be asked questions about hunger and comfort levels throughout the stay.
Key facts
- Study ID
- NCT01778556
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 25
- Starts
- 2013-01-26
- Expected to finish
- 2018-02-23
- Last updated by the study team
- 2019-11-13
Who can join
Age: 14 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- In leptin treated subjects only, the following exclusion criteria apply:
- Poorly controlled diabetes at study entry (hemoglobin A1c greater than or equal to 9%)
- Poorly controlled hypertriglyceridemia at study entry (serum triglycerides > 800 mg/dL)
- Extreme hypertriglyceridemia prior to leptin (triglycerides greater than 2000 mg/dL at initiation of leptin treatment)
- History of chronic or recurrent acute pancreatitis (> 1 episode), or a single episode of pancreatitis while receiving leptin treatment
- Lipase greater than the upper limit of normal (491 units/L) at study entry
- In all subjects (leptin treated and leptin naive), the following exclusion criteria apply:
- Known HIV infection or HIV-associated lipodystrophy
- History of diabetic ketoacidosis
- Active inflammatory disease (e.g. dermatomyositis)
- Change in diabetes or lipid-lowering medications within the past 6 weeks
- Estimated glomerular filtration rate < 30 mL/minute
- Current or recent (past 2 weeks) use of systemic glucocorticoids
- Inadequately controlled hypothyroidism (TSH < 0.4 or >4 mcIU/L) or change in thyroid medication in the past 8 weeks.
- Pregnancy or breast-feeding
- Psychiatric disorder impeding competence or compliance
- Any medical condition or medication that will increase risk to the subject (e.g. ischemic heart disease, decompensated liver disease) or that will interfere with interpretation of study data (e.g. Cushing s syndrome).
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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