Effects of metreleptin on pregnancy outcomes in women with lipodystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the link between obesity and infectious diseases with diet and melatonin

  This study is testing how obesity affects the risk of getting infections and whether a Mediterranean diet and melatonin can help people with obesity and related health issues feel better.

  Recruiting at 4 sites Federico II University · Naples and 3 other locations · NCT06236932

• Assessing fat tissue in people with familial partial lipodystrophy

  This study is testing a new way to look at fat tissue in people with familial partial lipodystrophy to better understand how their bodies store and use fat compared to healthy individuals.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05996536

• Evaluating Metreleptin for Partial Lipodystrophy

  This study is testing if daily injections of Metreleptin can help people with partial lipodystrophy manage their symptoms better.

  Recruiting at 9 sites Phase 4 Amryt Pharma · Lille and 11 other locations · NCT06484868

• Blocking growth hormone to help with severe insulin resistance

  This study is testing if a medication that blocks growth hormone can help people with severe insulin resistance feel better and improve their metabolism.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05470504

• Registry for patients treated with metreleptin for lipodystrophy

  This study is collecting information from patients with lipodystrophy who are being treated with metreleptin to see how well it works and what side effects it might cause in real life.

  Recruiting at 20 sites Chiesi Farmaceutici S.p.A. · Birmingham, Alabama and 27 other locations · NCT02325674

• Identifying insulin-resistant PCOS with LMNA-related lipodystrophy in young women

  We’re testing whether women with a genetic insulin resistance and lipodystrophy differ from women with PCOS by age and BMI matching.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07412028

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.