Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called metreleptin, which helps people with a condition called lipodystrophy (where the body has too little fat), might affect pregnancy outcomes. Researchers want to understand whether taking metreleptin during pregnancy is helpful or harmful for both the mother and the baby. They are collecting information from women over 18 who have had pregnancies, whether or not they used metreleptin, as well as from children of these women if the mothers took the drug during pregnancy.

Eligible participants will have a single study visit, which can be done in-person, over the phone, or through a video call. During this visit, women will answer questions about their pregnancies and any health issues they experienced. They may also need to provide a blood sample, and children may be asked to do the same. This study is currently recruiting participants, and it's a chance to contribute to understanding the effects of metreleptin during pregnancy for future mothers and their babies.

Gender

ALL

Eligibility 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.