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

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Brief Title

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

Official Title

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

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....
    

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:

        1. 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.

        2. 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 Type

Observational


Primary Outcome

type and frequency of pregnancy complications


Condition

Lipodystrophy


Study Arms / Comparison Groups

 off-spring of above
Description:  Off-spring of the women who took metreleptin during her pregnancy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

90

Start Date

September 7, 2022

Completion Date

March 1, 2025

Primary Completion Date

March 1, 2025

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.
      

Gender

All

Ages

6 Months - N/A

Accepts Healthy Volunteers

No

Contacts

Rebecca J Brown, M.D., (301) 402-6371, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05419037

Organization ID

10000757

Secondary IDs

000757-DK

Responsible Party

Sponsor

Study Sponsor

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


Study Sponsor

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


Verification Date

September 7, 2022