Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD) (NCT05996536) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)
United States14 participantsStarted 2024-01-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Age \>= 18 and \<= 65 years
✓. Agreement to adhere to Lifestyle Considerations throughout study duration.
✓. Weight stability (per the subject) within approximately 3 kg in the 3 months prior to screening, with no plans to actively gain or lose weight during the study period.
✓. Clinical diagnosis of partial lipodystrophy based on reduction in adipose tissue outside the normal range in selected adipose depots (including, at a minimum, the gluteofemoral depot) with preservation of adipose tissue in other depots.
✓. Adequate abdominal and thigh adipose tissue for feasible subcutaneous fat biopsy, as judged by the investigator.
✓. Sex
✓. Age plus-minus 5 years
Exclusion criteria
✕. Uncontrolled diabetes, defined as HbA1C \>8% at screening.
What they're measuring
1
Feasibility of performing subcutaneous adipose tissue biopsy in patients with partial lipodystrophy.
Timeframe: 10 days
2
To determine the feasibility of detecting labeled TG/FA in femoral adipose tissue biopsy samples in patients with lipodystrophy, as compared to abdominal adipose tissue biopsy samples in the same patients, and as compared to controls.
Timeframe: 10 days
Trial details
NCT IDNCT05996536
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
✕. Use of insulin secretagogues (sulfonylureas) in week prior to Study Visit 1.
✕. Changes in insulin dose \>30% of total daily dose in the 2 weeks prior to Study Visit 1.
✕. Use of niacin in the week prior to Study Visit 1.
✕. Use of antiplatelets that cannot be safely held for the appropriate duration prior to each biopsy visit, including Plavix (one week prior to biopsy), aspirin (one week prior to biopsy) and NSAIDS (48 hours prior to biopsy).
✕. Chronic use of anticoagulant medications that cannot be safely stopped for an appropriate duration of time prior to a biopsy procedure.
✕. Lipemia defined as non-fasting triglycerides of \>1000 mg/dL at screening.
✕. Renal dysfunction defined as GFR \<60 mL/min/1.73 m\^2 at screening.