RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study to Assess Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)

Quick Facts

Study Start:2024-01-03

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05996536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Megan S Startzell, R.N.

CONTACT

(301) 402-6371

megan.startzell@nih.gov

Rebecca J Brown, M.D.

CONTACT

(301) 594-0609

brownrebecca@mail.nih.gov

Principal Investigator

Rebecca J Brown, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Rebecca J Brown, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2024-01-03

Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

Lipodystrophy
Adipose Tissue

Additional Relevant MeSH Terms

Lipodystrophy