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Familial Partial Lipodystrophy Study (FPL)

Primary Purpose

Lipodystrophy, Familial Partial

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High fat mixed meal

About this trial

This is an interventional diagnostic trial for Lipodystrophy, Familial Partial focused on measuring FPL, adipose tissue, diabetes, dyslipidemia, metabolic, hyperinsulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of lipodystrophy (decreased subcutaneous fat)
Family history of lipodystrophy
Normal control subject

Exclusion Criteria:

Inability to provide informed consent
Hemoglobin < 10g%

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Group 1: Healthy Subject

Group 2: FPL Subject

Arm Description

Healthy Subject (Control) will undergo assessments before and after ingesting a high fat mixed meal.

FPL Subject will undergo assessments before and after ingesting a high fat mixed meal.

Outcomes

Primary Outcome Measures

Upper body muscle strength measured by chest press dynamometry

Change in fractional mitochondrial protein synthesis rates

Lower body muscle strength measured by knee extension

Secondary Outcome Measures

Full Information

NCT ID

NCT02858830

First Posted

May 19, 2016

Last Updated

November 23, 2021

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02858830

Brief Title

Familial Partial Lipodystrophy Study

Acronym

FPL

Official Title

Genetic and Metabolic Basis of Familial Partial Lipodystrophy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

April 14, 2017 (Actual)

Study Completion Date

April 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Studying patients with rare adipose tissue disorders may help the investigators to better understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and thus have an enormous impact on public health.

Detailed Description

A systematic study of body fat distribution is necessary to better define the phenotypic spectrum of FPL, and to better recognize FPL in patients with Metabolic Syndrome. Similarly, genetic studies in these patients will not only help better characterize the genotype-phenotype relationship, but is also likely to help identify other genes involved in regulation of lipid homeostasis, as some patients may not have any of the known mutations. The Investigators will systematically study mitochondrial protein quality and function under fasting and fed state in relation to intramyocellular and circulating plasma lipid levels, and compare with age, sex and BMI-matched individuals. The Investigators will also study the rate of de-novo protein synthesis to determine if hyperinsulinemia affects both muscle protein anabolism and catabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lipodystrophy, Familial Partial

Keywords

FPL, adipose tissue, diabetes, dyslipidemia, metabolic, hyperinsulinemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Healthy Subject

Arm Type

Other

Arm Description

Healthy Subject (Control) will undergo assessments before and after ingesting a high fat mixed meal.

Arm Title

Group 2: FPL Subject

Arm Type

Other

Arm Description

FPL Subject will undergo assessments before and after ingesting a high fat mixed meal.

Intervention Type

Other

Intervention Name(s)

High fat mixed meal

Primary Outcome Measure Information:

Title

Upper body muscle strength measured by chest press dynamometry

Time Frame

Before consumption of a high fat mixed meal

Title

Change in fractional mitochondrial protein synthesis rates

Time Frame

Before and after consumption of a high fat mixed meal (approximately 4 hours after the meal)

Title

Lower body muscle strength measured by knee extension

Time Frame

Before consumption of a high fat mixed meal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of lipodystrophy (decreased subcutaneous fat) Family history of lipodystrophy Normal control subject Exclusion Criteria: Inability to provide informed consent Hemoglobin < 10g%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinaya Simha, MBBS, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Familial Partial Lipodystrophy Study

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