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Familial Partial Lipodystrophy Study

NCT ID: NCT02858830

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-04-14

Brief Summary

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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

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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.

Conditions

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Lipodystrophy, Familial Partial

Keywords

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FPL adipose tissue diabetes dyslipidemia metabolic hyperinsulinemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1: Healthy Subject

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

Group Type OTHER

High fat mixed meal

Intervention Type OTHER

Group 2: FPL Subject

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

Group Type OTHER

High fat mixed meal

Intervention Type OTHER

Interventions

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High fat mixed meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of lipodystrophy (decreased subcutaneous fat)
2. Family history of lipodystrophy
3. Normal control subject

Exclusion Criteria

1. Inability to provide informed consent
2. Hemoglobin \< 10g%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Vinaya Simha, M.B.B.S., M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinaya Simha, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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

Mayo Clinic Clinical Trials

Other Identifiers

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15-009144

Identifier Type: -

Identifier Source: org_study_id