An observational study in Lipodystrophy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 6 Months to 98 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
Background:
Lipodystrophy is a health problem in which the body does not have enough fat tissue. People with lipodystrophy may not make enough of the hormone leptin. Leptin regulates hunger. Low leptin levels trigger hunger. People with lipodystrophy can have many health problems. They may take a drug (metreleptin) that mimics leptin. Little is known about how taking metreleptin may affect a pregnancy. Metreleptin may be helpful or harmful to pregnant women. It may also affect the health of the child who is born.
Objective:
This natural history study will collect data about the effects of taking metreleptin while pregnant.
Eligibility:
Women aged 18 years or older with lipodystrophy who have been pregnant. Women who did and who did not take metreleptin during their pregnancies are needed. Children of women with lipodystrophy who took this drug during pregnancy are also needed.
Design:
Participants will have 1 study visit. This visit may be by phone, by telehealth, or in-person.
Participants will answer questions about their pregnancies.
They will discuss any health problems they had.
They will be asked about any medicines they took before and during their pregnancies.
They will be asked about the health of their children.
Participants medical records will be reviewed.
Participants may need to provide a blood sample. They may also be asked to provide a sample of breastmilk.
Participants children may also be asked to provide a blood sample....
Study Description:
Single-site cross-sectional study of women with lipodystrophy who had pregnancies during which they were or were not exposed to metreleptin, and the offspring of women whose offspring were exposed to metreleptin during pregnancy. The study involves secondary use of data and samples from other studies in which these subjects participated, review of outside medical records, and collection of a single blood specimen if a biobanked specimen is not available.
The hypotheses are:
Objectives:
Primary: Determine pregnancy outcomes, including type and frequency of pregnancy complications in women treated with metreleptin during pregnancy vs. untreated pregnancies.
Secondary: Determine if anti-leptin antibodies are detectable in offspring of women treated with metreleptin during pregnancy.
Endpoints:
Primary Endpoint: We will quantify a set of pregnancy and offspring outcomes and complications.
Secondary Endpoints: Frequency and type of anti-leptin antibodies.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's planned enrollment of 90 is below the median of 104 across 34 observational studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women who were pregnant while taking metreleptin and their off-spring will be evaluated.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Women with lipodystrophy who had pregnancies with or without use of metreleptin:
Offspring of women with lipodystrophy who had pregnancies while taking metreleptin:
Note that subjects treated with metreleptin during pregnancy may participate in this study regardless of the participation of their offspring.
EXCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must not meet any of the following criteria:
Pregnancy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Off-spring of the women who took metreleptin during her pregnancy.
Women who took metreleptin during pregnancy.
type and frequency of pregnancy complications
We will quantify a set of pregnancy and offspring outcomes and complications.
Time frame: at end of study
Plan to share: No — Result of the study will be disseminated to participants upon publication.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) →