Clinical Trials Logo

Clinical Trial Summary

Background: People with familial partial lipodystrophy (FPLD) do not store fat in the body normally. This can lead to serious illnesses such as diabetes and heart disease. To learn more about FPLD, researchers want to compare the fat tissue in people with this disease to the fat tissue of healthy people. Objective: To collect and analyze samples of fat tissue in people with and without FPLD. Eligibility: People aged 18 to 65 years with FPLD. Healthy adults are also needed. Design: Participants will be screened. They will have a physical exam. The size and shape of their body will be measured. They will have an imaging scan to measure their bones, muscle, and fat. Participants will be given heavy water to drink at home. The water contains a tracer to help measure the fat in their blood. They will drink 1 vial 3 times a day. After drinking the water for 9 days, participants will come to the clinic for a 3-day stay. They will eat only foods provided by the hospital; the foods will contain tracers. A needle will be inserted into a vein in the arm; participants will receive infusions of other tracers through this needle into their blood; this needle will also be used to draw blood samples for testing. On their third day in the clinic, participants will have biopsies: Small samples of fat will be removed from under the skin on the belly and thigh. Participants may return for a follow-up visit 8 days after leaving the clinic. Blood draws and fat tissue biopsies will be repeated.


Clinical Trial Description

Study Description: The feasibility of adipose tissue triglyceride labeling in patients with FPLD will be assessed in this non-interventional protocol. Specifically, subjects with FPLD (n=5) and control subjects without FPLD (n=5) will undergo isotope administration followed by abdominal and femoral subcutaneous fat biopsies. Objectives: Primary objective: (1) To establish the technique of subcutaneous femoral adipose tissue biopsy in patients with FPLD, and subsequently, (2) to establish the feasibility of detecting labeled TG/FA in these adipose tissue biopsy samples. Secondary objectives: (1) To determine metabolic fluxes in healthy volunteers and patients with FPLD. (2) To determine if peripheral subcutaneous adipocytes are capable of fatty acid uptake and retention in patients with FPLD. (3) To assess standard metabolic parameters impacted by adipose fat storage capacity. (4) To assess different forms of circulating fat. (5) To determine feasibility of measuring adipose tissue lipoprotein lipase (LPL) activity. Endpoints: Primary Endpoints: (1) Feasibility of performing subcutaneous femoral adipose tissue biopsy in patients with FPLD and (2) presence of detectable stable isotope labeling in adipose tissue specimens. Secondary Endpoints: (1) Blood labeling of glucose, glycerol, palmitate, and saponified fatty acids and other metabolites, as feasible; (2) quantity of stable isotope labeling in adipose tissue specimens; (3) blood glucose, insulin, NEFA, beta-OH-butyrate; (4) blood TG, VLDL, chylomicrons, NEFA and complete lipoprotein panel by NMR; (5) adipose tissue LPL activity and (6) adipose tissue histologic analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05996536
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact Megan S Startzell, R.N.
Phone (301) 402-6371
Email megan.startzell@nih.gov
Status Recruiting
Phase
Start date January 3, 2024
Completion date June 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05419037 - Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
Recruiting NCT03059121 - The Cleveland Cardiometabolic Cohort
Completed NCT00656175 - Raltegravir Therapy for Women With HIV and Fat Accumulation Phase 2
Completed NCT00006185 - Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome Phase 1
Completed NCT00202241 - The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS N/A
Recruiting NCT02262832 - Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy Phase 3
Completed NCT01679197 - Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy Phase 2
Completed NCT02647853 - Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Phase 1
Active, not recruiting NCT00715546 - Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy Phase 1
Completed NCT00069004 - A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth N/A
Completed NCT00025883 - Leptin to Treat Lipodystrophy Phase 2
Completed NCT00001142 - Metabolism and Body Shape of Healthy Children and Children With Chronic Infections N/A
Active, not recruiting NCT02262806 - Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy Phase 2
Completed NCT02258685 - Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.
Completed NCT00192621 - Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects Phase 4
Completed NCT00006190 - A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy Phase 4
Recruiting NCT05930106 - Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management N/A
Completed NCT00004329 - Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy N/A
Recruiting NCT04656054 - Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance
Completed NCT00082628 - Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients Phase 3