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NCT05419037 · ClinicalTrials.gov registry record
Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
A clinical trial of Lipodystrophy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- 90
- Enrollment target
- 1
- Study location
NCT05419037 is a study of Lipodystrophy that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 90 participants, below the 126-participant average among 11 other Lipodystrophy trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05419037, a study of Lipodystrophy, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- 90 participants
- Enrollment target
- 1
- Study location
Study 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....
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-09-07 |
| Est. Completion | 2029-03-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05419037
The ClinicalTrials.gov registry entry for NCT05419037 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 11 other Lipodystrophy trials with a reported enrollment target (29% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lipodystrophy appearing as the primary indexed condition, and to 0 interventions.
NCT05419037 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05419037 about?
NCT05419037 is a clinical study titled "Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy". 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 d...
What is the current status of trial NCT05419037?
This trial is currently recruiting. The enrollment target is 90 participants. The study started on 2022-09-07. Estimated completion is 2029-03-01.
What conditions does trial NCT05419037 study?
This clinical trial studies the following conditions: Lipodystrophy.
Who is sponsoring clinical trial NCT05419037?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05419037 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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