Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996536
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-08-16
Brief Title:
Feasibility of Adipose Tissue Triglyceride TG Labelling in Familial Partial Lipodystrophy FPLD
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study to Assess Feasibility of Adipose Tissue Triglyceride TG Labelling in Familial Partial Lipodystrophy FPLD
Status:
RECRUITING
Status Verified Date:
2024-09-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 n5 and control subjects without FPLD n5 will undergo isotope administration followed by abdominal and femoral subcutaneous fat biopsies
Objectives
Primary objective
1 To establish the technique of subcutaneous femoral adipose tissue biopsy in patients with FPLD and subsequently 2 to establish the feasibility of detecting labeled TGFA in these adipose tissue biopsy samples
Secondary objectives
1 To determine metabolic fluxes in healthy volunteers and patients with FPLD 2 To determine if peripheral subcutaneous adipocytes are capable of fatty acid uptake and retention in patients with FPLD 3 To assess standard metabolic parameters impacted by adipose fat storage capacity 4 To assess different forms of circulating fat 5 To determine feasibility of measuring adipose tissue lipoprotein lipase LPL activity
Endpoints
Primary Endpoints
1 Feasibility of performing subcutaneous femoral adipose tissue biopsy in patients with FPLD and 2 presence of detectable stable isotope labeling in adipose tissue specimens
Secondary Endpoints
1 Blood labeling of glucose glycerol palmitate and saponified fatty acids and other metabolites as feasible 2 quantity of stable isotope labeling in adipose tissue specimens 3 blood glucose insulin NEFA beta-OH-butyrate 4 blood TG VLDL chylomicrons NEFA and complete lipoprotein panel by NMR 5 adipose tissue LPL activity and 6 adipose tissue histologic analysis
The feasibility of adipose tissue triglyceride labeling in patients with FPLD will be assessed in this non-interventional protocol Specifically subjects with FPLD n5 and control subjects without FPLD n5 will undergo isotope administration followed by abdominal and femoral subcutaneous fat biopsies
Objectives
Primary objective
1 To establish the technique of subcutaneous femoral adipose tissue biopsy in patients with FPLD and subsequently 2 to establish the feasibility of detecting labeled TGFA in these adipose tissue biopsy samples
Secondary objectives
1 To determine metabolic fluxes in healthy volunteers and patients with FPLD 2 To determine if peripheral subcutaneous adipocytes are capable of fatty acid uptake and retention in patients with FPLD 3 To assess standard metabolic parameters impacted by adipose fat storage capacity 4 To assess different forms of circulating fat 5 To determine feasibility of measuring adipose tissue lipoprotein lipase LPL activity
Endpoints
Primary Endpoints
1 Feasibility of performing subcutaneous femoral adipose tissue biopsy in patients with FPLD and 2 presence of detectable stable isotope labeling in adipose tissue specimens
Secondary Endpoints
1 Blood labeling of glucose glycerol palmitate and saponified fatty acids and other metabolites as feasible 2 quantity of stable isotope labeling in adipose tissue specimens 3 blood glucose insulin NEFA beta-OH-butyrate 4 blood TG VLDL chylomicrons NEFA and complete lipoprotein panel by NMR 5 adipose tissue LPL activity and 6 adipose tissue histologic analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001651-DK | None | None | None |