Recruiting

Insulin Resistance

Sponsor:

Yale University

Code:

NCT02193295

Conditions

Insulin Resistance

NAFLD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Caloric Restriction

Study Details

Brief summary:

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

Insulin Resistance

NAFLD

Study ID

NCT02193295

Start date

Oct, 2002

Status verified date

Jun, 2026

Completion date

Dec, 2034

Anticipated

Primary completion date

Oct, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy, sedentary, non-smoking and not taking any medications other than birth control pills.
  • Hematocrit >35%
  • Subjects will have no systemic or organ disease including diabetes.
  • Subjects will have no history eating disorders.
  • Women must be using a form of birth control (sexual abstinence, birth control pills, Norplant, IUD or condoms) and will be studied between day 0 and 7 of their menstrual cycle.
  • Those who are taking birth control pills or have had a hysterectomy may be studied at any time.
  • Physical activity will be assessed using a standard questionnaire with an activity index cut off at 2.3.

Exclusion Criteria:

  • Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes.

Lactose intolerance Any blood count, clotting abnormalities HYpertriglyceridemeia (TG over 100 mg/dL)

  • Hematocrit <35%.
  • Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent.
  • Subjects who have a regular exercise regimen will not be enrolled.
  • Metal implants and/or body piercing, which cannot be removed before the MR studies.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Lifestyle Intervention

Caloric Restriction to reverse lipid-induced insulin resistance.

experimental: Baseline Assessment of Hepatic Mitochondrial Fat Oxidation

Tracer study to assess hepatic mitochondrial fat oxidation (PINTA).

Interventions

Caloric Restriction

Dietary intervention to reduce lipid content in liver and muscle with minimal overall weight loss. Weekly visits for measurements of body weight, body composition, blood glucose and MRS measurements of liver and muscle lipid.

Primary outcome measure

  • Improvements in insulin sensitivity [ Time Frame: up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction ]

Central Contacts and Locations

Central contacts

Kitt Petersen, MD

203-785-5447kitt.petersen@yale.edu

Locations

Yale Center for Clinical Investigation HRU

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Kitt Petersen, MD

203-688-4106

Principal Investigator:

Kitt Petersen, MD

More Information

Sponsor

Yale University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Weight Reduction
  • Caloric Restriction
  • Euglycemic Hyperinsulinemic Clamp
  • Magnetic Resonance Spectroscopy
  • PINTA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-22.