Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT02193295

Reversal of Lipid-Induced Insulin Resistance

Led by Yale University · Updated on 2025-05-16

250

Participants Needed

2

Research Sites

1678 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to examine whether weight reduction decreases intramyocellular (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue in people who are insulin resistant and have a family history of type 2 diabetes. Hepatic mitochondrial oxidation will be assesses using a 3 hour triple tracer study (D7 glucose, 3-13C lactate and 13C4 beta-hydroxybutyrate).

CONDITIONS

Official Title

Reversal of Lipid-Induced Insulin Resistance

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy, sedentary, non-smoking adults not taking medications other than birth control pills
  • Hematocrit level greater than 35%
  • No systemic or organ disease including diabetes
  • No history of eating disorders
  • Women must be using birth control (sexual abstinence, birth control pills, Norplant, IUD, or condoms) and studied between days 0 and 7 of their menstrual cycle
  • Women taking birth control pills or with hysterectomy may be studied at any time
  • Physical activity level with an activity index cutoff at 2.3
Not Eligible

You will not qualify if you...

  • Any individual not meeting inclusion criteria, including history of eating disorders or systemic diseases such as diabetes
  • Lactose intolerance
  • Blood count or clotting abnormalities
  • Hypertriglyceridemia (triglycerides over 100 mg/dL)
  • Hematocrit less than 35%
  • Women of childbearing potential not using contraception or not abstinent
  • Subjects with a regular exercise regimen
  • Metal implants or body piercings that cannot be removed before MRI studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Magnetic Resonance Research Center (MRRC)

New Haven, Connecticut, United States, 06511

Enrolling by Invitation

2

Yale Center for Clinical Investigation HRU

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

K

Kitt Petersen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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