Fat storage mystery: new study probes rare disease
NCT ID NCT05996536
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study looks at how fat is stored in people with familial partial lipodystrophy (FPLD), a condition that can lead to diabetes and heart disease. Researchers will compare fat tissue from people with FPLD and healthy volunteers. Participants drink special water and get infusions to track fat, then provide small fat samples from the belly and thigh.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with partial lipodystrophy and non-lipodystrophic controls.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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