Status:
RECRUITING
Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Lipodystrophy
Eligibility:
All Genders
18-65 years
Brief 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, r...
Detailed 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 contr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Common inclusion criteria (FPLD and Controls):
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
- FPLD-specific inclusion criteria:
- 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.
- CONTROL MATCHING CRITERIA:
- When possible, control subjects will be individuals matched 1:1 with the FPLD subjects based on the following criteria (in order of priority). These criteria will be considered when assessing eligibility but are not strict inclusion criteria.
- Sex
- Age plus-minus 5 years
- Diabetic status
- Abdominal circumference plus-minus 10 cm
- Height plus-minus 5 cm
- EXCLUSION CRITERIA:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Uncontrolled diabetes, defined as HbA1C \>8% at screening.
- 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.
- Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).
- Positive pregnancy test or breastfeeding at screening.
- History of HIV, hepatitis B or C infection.
- History of acquired lipodystrophy.
- Clinically significant abnormalities in thyroid function, liver function, blood counts, or blood minerals as assessed by screening labs.
- Inability to comply with planned study procedures.
- Inability of subject to understand and the willingness to sign a written informed consent document.
- Any condition which in the opinion of the investigator increases risk to subjects, prevents subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.
Exclusion
Key Trial Info
Start Date :
January 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05996536
Start Date
January 3 2024
End Date
June 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892