Status:
RECRUITING
Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Lipodystrophy
Eligibility:
All Genders
6-98 years
Brief Summary
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 lept...
Detailed Description
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 offspr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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:
- Female, aged \>= 18 years
- Clinical diagnosis of non-HIV associated generalized or partial lipodystrophy
- History of one or more pregnancies
- Offspring of women with lipodystrophy who had pregnancies while taking metreleptin:
- Males or females aged \>=1 month
- Mothers took metreleptin during their pregnancy
- Availability of a biobanked blood specimen or willingness to provide a blood specimen
- 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:
- Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with \*)
- Pregnancy.
- Subjects who otherwise meet inclusion/exclusion criteria but who are not reachable to obtain informed consent may be included under a waiver of consent.
Exclusion
Key Trial Info
Start Date :
September 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05419037
Start Date
September 7 2022
End Date
March 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892