Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
Study Details
Study Description
Brief Summary
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 offspring were exposed to metreleptin during pregnancy. The study involves secondary use of data and samples from other studies in which these subjects participated, review of outside medical records, and collection of a single blood specimen if a biobanked specimen is not available.
The hypotheses are:
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Pregnancy complications will be less prevalent and severe in women with lipodystrophy who took metreleptin during pregnancy compared to those who did not, due the beneficial effects of metreleptin on metabolic complications of lipodystrophy.
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Anti-leptin antibodies may be detected in some offspring born to women with lipodystrophy treated with metreleptin during pregnancy, but these antibodies will not be associated with adverse health outcomes.
Objectives:
Primary: Determine pregnancy outcomes, including type and frequency of pregnancy complications in women treated with metreleptin during pregnancy vs. untreated pregnancies.
Secondary: Determine if anti-leptin antibodies are detectable in offspring of women treated with metreleptin during pregnancy.
Endpoints:
Primary Endpoint: We will quantify a set of pregnancy and offspring outcomes and complications.
Secondary Endpoints: Frequency and type of anti-leptin antibodies....
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 offspring were exposed to metreleptin during pregnancy. The study involves secondary use of data and samples from other studies in which these subjects participated, review of outside medical records, and collection of a single blood specimen if a biobanked specimen is not available.
The hypotheses are:
-
Pregnancy complications will be less prevalent and severe in women with lipodystrophy who took metreleptin during pregnancy compared to those who did not, due the beneficial effects of metreleptin on metabolic complications of lipodystrophy.
-
Anti-leptin antibodies may be detected in some offspring born to women with lipodystrophy treated with metreleptin during pregnancy, but these antibodies will not be associated with adverse health outcomes.
Objectives:
Primary: Determine pregnancy outcomes, including type and frequency of pregnancy complications in women treated with metreleptin during pregnancy vs. untreated pregnancies.
Secondary: Determine if anti-leptin antibodies are detectable in offspring of women treated with metreleptin during pregnancy.
Endpoints:
Primary Endpoint: We will quantify a set of pregnancy and offspring outcomes and complications.
Secondary Endpoints: Frequency and type of anti-leptin antibodies.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| off-spring of above Off-spring of the women who took metreleptin during her pregnancy. |
|
| Women with past pregnancy on metreleptin Women who took metreleptin during pregnancy. |
Outcome Measures
Primary Outcome Measures
- type and frequency of pregnancy complications [at end of study]
We will quantify a set of pregnancy and offspring outcomes and complications.
Eligibility Criteria
Criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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Women with lipodystrophy who had pregnancies with or without use of metreleptin:
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Female, aged >= 18 years
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Clinical diagnosis of non-HIV associated generalized or partial lipodystrophy
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History of one or more pregnancies
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Offspring of women with lipodystrophy who had pregnancies while taking metreleptin:
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Males or females aged >=1 month
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Mothers took metreleptin during their pregnancy
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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:
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Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with *)
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Pregnancy.
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Subjects who otherwise meet inclusion/exclusion criteria but who are not reachable to obtain informed consent may be included under a waiver of consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Rebecca J Brown, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10000757
- 000757-DK