NCT02858830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2017

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

May 19, 2016

Last Update Submit

November 23, 2021

Conditions

Lipodystrophy, Familial Partial

Keywords

FPLadipose tissuediabetesdyslipidemiametabolichyperinsulinemia

Outcome Measures

Primary Outcomes (3)

  • Upper body muscle strength measured by chest press dynamometry

    Before consumption of a high fat mixed meal

  • Change in fractional mitochondrial protein synthesis rates

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

  • Lower body muscle strength measured by knee extension

    Before consumption of a high fat mixed meal

Study Arms (2)

Group 1: Healthy Subject

OTHER

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

Other: High fat mixed meal

Group 2: FPL Subject

OTHER

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

Other: High fat mixed meal

Interventions

High fat mixed mealOTHER
Group 1: Healthy SubjectGroup 2: FPL Subject

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to provide informed consent
  • Hemoglobin \< 10g%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Lipodystrophy, Familial PartialDiabetes MellitusDyslipidemiasHyperinsulinism

Condition Hierarchy (Ancestors)

LaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism, Inborn ErrorsLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Vinaya Simha, MBBS, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 19, 2016

First Posted

August 8, 2016

Study Start

August 1, 2016

Primary Completion

April 14, 2017

Study Completion

April 14, 2017

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)