RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

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

Quick Facts

Study Start:2022-09-07
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05419037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 98 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with lipodystrophy who had pregnancies with or without use of metreleptin:
  2. * Female, aged \>= 18 years
  3. * Clinical diagnosis of non-HIV associated generalized or partial lipodystrophy
  4. * History of one or more pregnancies
  5. * Offspring of women with lipodystrophy who had pregnancies while taking metreleptin:
  6. * Males or females aged \>=1 month
  7. * Mothers took metreleptin during their pregnancy
  8. * Availability of a biobanked blood specimen or willingness to provide a blood specimen
  1. * Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with \*)
  2. * Pregnancy.
  3. * 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

Study Contact

Megan S Startzell, R.N.
CONTACT
(301) 402-6371
megan.startzell@nih.gov
Rebecca J Brown, M.D.
CONTACT
(301) 594-0609
brownrebecca@mail.nih.gov

Principal Investigator

Rebecca J Brown, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Rebecca J Brown, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-07
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2022-09-07
Study Completion Date2025-03-01

Terms related to this study

Keywords Provided by Researchers

  • Metreleptin
  • Pregnancy
  • Off-Spring
  • Natural History

Additional Relevant MeSH Terms

  • Lipodystrophy