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NCT03087253 · ClinicalTrials.gov registry record
The LD Lync Study - Natural History Study of Lipodystrophy Syndromes
A clinical trial of Lipodystrophy (Genetic or Acquired, Non HIV), sponsored by University of Michigan.
- Recruiting
- Registry status
- 500
- Enrollment target
- 4
- Study locations
NCT03087253: Recruiting study of Lipodystrophy (Genetic or Acquired, Non HIV), sponsored by University of Michigan.
NCT03087253 is a study of Lipodystrophy (Genetic or Acquired, Non HIV) that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 500 participants. The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03087253, a study of Lipodystrophy (Genetic or Acquired, Non HIV), is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 4
- Study locations
Study Summary
Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States. These rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems, atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and other morbidities complicate the lives of these patients. In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA, PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA); autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1) have been identified. However, there is paucity of information about the natural history of these rare syndromes, especially genotype-specific causes of morbidity and mortality. To overcome the problems outlined above, this multicenter, collaborative, prospective, observational natural history cohort study will be conducted on approximately 500 patients with genetic or acquired lipodystrophy syndromes. Patients will be assessed on a yearly basis for approximately 5 to 7 years to collect robust clinical, metabolic, morbidity and mortality data. Medical history and patient questionnaires will be completed on a yearly basis by patients registered in the study. Clinical data such as vitals, laboratory results and anthropometric measurements will also be collected from patients' medical records if available.
Primary Outcome
Number of subjects with diabetes mellitus or who develop diabetes mellitus
Conditions Studied
Study Locations (4)
Maryland
- National Institutes of Health - Bethesda
Michigan
- University of Michigan - Ann Arbor
Ceará
- Federal University of Ceará - Fortaleza
Other
- Izmir Biomedicine and Genome Center - Izmir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2034-03 |
What NCT03087253 shows while recruiting
NCT03087253 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Lipodystrophy (Genetic or Acquired, Non HIV) appearing as the primary indexed condition, and to 0 interventions.
NCT03087253 reports a single indexed study location in Maryland, Michigan, Ceará.
Frequently Asked Questions
What is clinical trial NCT03087253 about?
NCT03087253 is a clinical study titled "The LD Lync Study - Natural History Study of Lipodystrophy Syndromes". Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States. These rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dys...
What is the current status of trial NCT03087253?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2018-02-27. Estimated completion is 2034-03.
What conditions does trial NCT03087253 study?
This clinical trial studies the following conditions: Lipodystrophy (Genetic or Acquired, Non HIV).
Who is sponsoring clinical trial NCT03087253?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03087253 being conducted?
This trial has 4 study locations across Maryland, Michigan, Ceará. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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