NCT02717832

Brief Summary

The overall goal of this project is to identify factors that "protect" some obese adults from becoming insulin resistant. Identifying mechanisms that help protect some obese adults from developing insulin resistance could lead to novel, targeted therapeutic and/or preventative strategies for obese adults who are insulin resistant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable obesity

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

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 11, 2022

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

3.4 years

First QC Date

March 7, 2016

Results QC Date

April 8, 2022

Last Update Submit

May 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity

    baseline (this cross-sectional study involves only one insulin sensitivity measurement in a single visit for each participant)

Secondary Outcomes (1)

  • Resting Metabolic Rate

    baseline (this cross-sectional study involves only one Resting Metabolic Rate measurement in a single visit for each participant)

Study Arms (1)

Insulin Sensitivity

EXPERIMENTAL
Drug: hyperinsulinemic-euglycemic clamp

Interventions

Insulin Sensitivity

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index \[BMI\]: 30-40 kg/m2
  • Age: 18-45 years
  • All women must be pre-menopausal
  • Non-exerciser: no regularly planned exercise/physical activity

You may not qualify if:

  • Weight instability ≥ ±3kg ≥ 6 months
  • Medications known to affect lipid and/or glucose metabolism
  • Pregnancy or actively breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Results Point of Contact

Title
Dr. Jeffrey Horowitz
Organization
University of Michigan

Study Officials

  • Jeffrey F Horowitz

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Movement Science and Director, Substrate Metabolism Laboratory

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

August 9, 2019

Study Completion

August 9, 2019

Last Updated

May 11, 2022

Results First Posted

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations