Effects of metreleptin on pregnancy outcomes in women with lipodystrophy
Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
This study looks at how the medication metreleptin affects pregnancy outcomes in women with lipodystrophy compared to those who haven't taken it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 6 Months to 98 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05419037 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on pregnancy outcomes in women with lipodystrophy who have been treated with metreleptin compared to those who have not. It will involve a single study visit, which can be conducted via phone, telehealth, or in-person, and will utilize existing data and samples from previous studies. The primary objective is to determine the prevalence and severity of pregnancy complications in women treated with metreleptin, while secondary objectives include assessing the presence of anti-leptin antibodies in their offspring.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with a clinical diagnosis of lipodystrophy who have experienced one or more pregnancies.
Not a fit: Patients who do not have lipodystrophy or have not been pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of metreleptin during pregnancy, potentially improving outcomes for women with lipodystrophy.
How similar studies have performed: While there is limited data on the effects of metreleptin during pregnancy, similar studies on metabolic treatments have shown promising results in managing complications.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca J Brown, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Megan S Startzell, R.N.
- Email: megan.startzell@nih.gov
- Phone: (301) 402-6371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.