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Protocol Details

Short Term Effects of Leptin Withdrawal or Initiation in Lipodystrophy Independent of Energy Intake

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-DK-0057

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 14
Max Age: 70

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Lipodystrophy;
Leptin;
Energy Expenditure;
Diabetes;
Hypertriglyceridemia

Recruitment Keyword(s)

None

Condition(s)

Lipodystrophy

Investigational Drug(s)

Metreleptin

Investigational Device(s)

None

Intervention(s)

Drug: Leptin

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

INCLUSION CRITERIA:

-Age 14-70 years (children under age 18 will only be enrolled in the leptin-naive arm of the study

-Clinically-significant lipodystrophy as defined in protocol 02-DK-0022 (Long Term Efficacy of Leptin Replacement in the Treatment of Lipodystrophy). Relevant inclusion criteria for enrollment in protocol 02-DK-0022 are (summarized):

--Lipodystrophy identified by the study physician during physical examination as an absence of fat outside the range of normal

--Circulating leptin levels < 12.0 ng/mL in females and < 8.0 ng/mL in males

--Presence of at least one of the following metabolic abnormalities:

-- Diabetes as defined by the 2007 American Diabetes Association criteria:

1. Fasting plasma glucose greater than or equal to 126 mg/dL, or

2. 2-hour plasma glucose greater than or equal to 200 mg/dL following a 75 gram 91.75 gm/kg) oral

glucose load, or

3. Diabetic symptoms with a random plasma glucose greater than or equal to 200 mg/dL

-Fasting insulin >30 microU/mL

-Fasting hypertriglyceridemia >200 mg/dL

-Either:

--Leptin naive, with plans to initiate leptin treatment during the current study. For the purpose of this study, leptin naive will be defined as having received no exogenous leptin in the 4 months prior to study participation. Thus, subjects who previously received leptin therapy, discontinued, and wish to restart are eligible.

Or

--Leptin treated, meaning the subject has taken a stable dose of exogenous leptin for a minimum of 4 months (adults over age 18, only)

EXCLUSION CRITERIA:

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).

-Current alcohol or substance abuse.

-Subjects who have a known hypersensitivity to E. coli derived proteins.

-Subjects with acquired lipodystrophy and a hematologic abnormality such as neutropenia and/or lymphadenopathy.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Rebecca J. Brown, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 6-5942
10 CENTER DR
BETHESDA MD 20814
(301) 594-0609
brownrebecca@mail.nih.gov

Megan S. Startzell, R.N.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-5750
10 Center Drive
Bethesda, Maryland 20892
(301) 402-6371
megan.startzell@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01778556

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