NCT05419037 Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
| NCT ID | NCT05419037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Lipodystrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-09-07 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2022-09-07 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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....
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.
Contact & Investigator
Rebecca J Brown, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT05419037 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 98 Years, studying Lipodystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05419037 currently recruiting?
Yes, NCT05419037 is actively recruiting participants. Contact the research team at megan.startzell@nih.gov for enrollment information.
Where is the NCT05419037 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05419037 clinical trial?
NCT05419037 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is Rebecca J Brown, M.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 90 participants.