Reversal of Lipid-Induced Insulin Resistance

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT02193295
Status
Recruiting
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Conditions

  • Insulin Resistance
  • NAFLD

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Caloric Restriction — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Oct 31, 2002
Status verified
May 2025
Primary completion
Oct 31, 2034
Completion
Dec 31, 2034

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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).

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

Locations (2)

FacilityCityStateZIPSite coordinators
Magnetic Resonance Research Center (MRRC)New HavenConnecticut06511-
Yale Center for Clinical Investigation HRUNew HavenConnecticut06520
Kitt Petersen, MD
203-688-4106
Kitt Petersen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Magnetic Resonance Research Center (MRRC)· New Haven, CTYale Center for Clinical Investigation HRU· New Haven, CT

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