Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Aug 16, 2023

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ClinConnect Summary

This clinical trial is studying a condition called familial partial lipodystrophy (FPLD), where the body has trouble storing fat properly. This can lead to serious health issues like diabetes and heart disease. The researchers want to compare fat tissue from people with FPLD to that of healthy individuals to better understand how this condition affects the body.

To be eligible for the study, participants must be between 18 and 65 years old and have a confirmed diagnosis of FPLD. Healthy adults are also being recruited for comparison. Those who join the study can expect to undergo several tests, including physical exams, body measurements, and imaging scans. Participants will drink a special water for nine days and then stay at the clinic for three days, where they will consume specific foods and receive tracers through an IV to help analyze their fat. On the last day, small samples of fat will be taken from the belly and thigh. Follow-up visits will occur about a week later to repeat some tests. This study aims to gather important information that may help in understanding and treating FPLD.

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Eligibility criteria

• * 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:
• • 1. Stated willingness to comply with all study procedures and availability for the duration of the study
• • 2. Age \>= 18 and \<= 65 years
• • 3. Agreement to adhere to Lifestyle Considerations throughout study duration.
• • 4. 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:
• • 1. 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.
• • 2. 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.
• • 1. Sex
• • 2. Age plus-minus 5 years
• • 3. Diabetic status
• • 4. Abdominal circumference plus-minus 10 cm
• • 5. Height plus-minus 5 cm
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Uncontrolled diabetes, defined as HbA1C \>8% at screening.
• • 2. Use of insulin secretagogues (sulfonylureas) in week prior to Study Visit 1.
• • 3. Changes in insulin dose \>30% of total daily dose in the 2 weeks prior to Study Visit 1.
• • 4. Use of niacin in the week prior to Study Visit 1.
• • 5. 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).
• • 6. Chronic use of anticoagulant medications that cannot be safely stopped for an appropriate duration of time prior to a biopsy procedure.
• • 7. Lipemia defined as non-fasting triglycerides of \>1000 mg/dL at screening.
• • 8. Renal dysfunction defined as GFR \<60 mL/min/1.73 m\^2 at screening.
• • 9. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).
• • 10. Positive pregnancy test or breastfeeding at screening.
• • 11. History of HIV, hepatitis B or C infection.
• • 12. History of acquired lipodystrophy.
• • 13. Clinically significant abnormalities in thyroid function, liver function, blood counts, or blood minerals as assessed by screening labs.
• • 14. Inability to comply with planned study procedures.
• • 15. Inability of subject to understand and the willingness to sign a written informed consent document.
• • 16. 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.