RecruitingNot ApplicableNCT02193295

Reversal of Lipid-Induced Insulin Resistance


Sponsor

Yale University

Enrollment

250 participants

Start Date

Oct 1, 2002

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria12

  • 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.
  • 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.

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Interventions

BEHAVIORALCaloric 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.


Locations(2)

Magnetic Resonance Research Center (MRRC)

New Haven, Connecticut, United States

Yale Center for Clinical Investigation HRU

New Haven, Connecticut, United States

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NCT02193295


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