Mechanism of Insulin-Resistant in Lean Non-Diabetics

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00970099
First received: August 31, 2009
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The study is designed to test the following primary hypothesis:

  • Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects through changes in the major cellular signaling pathways and and/or their regulators.

Accordingly, the proposed study is designed to accomplish the following specific aims:

  • Quantitate how exercise training improves insulin sensitivity and decreases cardiovascular risk factors in a general population of lean, nondiabetic, insulin resistant subjects. Effects on known cardiovascular risk factors including blood pressure and serum lipoproteins will be evaluated. Change in regional adiposity will also be measured
  • Determine the effects of a program of regular aerobic exercise on in the insulin receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant subjects will be obtained before and after a hyperinsulinemic glucose clamp. This procedure will take place in the untrained state and after exercise training. The investigators will measure changes in the insulin receptor and the activity of the major components of the intracellular insulin signaling pathway. The investigators will also look intracellular proteins that regulate this signaling pathway.

Condition Intervention Phase
Insulin Resistance
Insulin Sensitivity
Type 2 Diabetes
Behavioral: exercise
Behavioral: Non exercise
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanism of Exercise Training in Lean Insulin-Resistant Non-Diabetics

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • insulin sensitivity and insulin signaling [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: February 2004
Study Completion Date: December 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise
12 week exercise regimen
Behavioral: exercise
Patients exercise under supervision on either a treadmill, Stair Master, or LifeCycle apparatus. Exercise frequency, duration, and intensity will be incrementally increased to minimize the risk of injury. During weeks 1-3, you will exercise for 30 minutes 3 days per week at 70- 80 % of your maximum heart rate (MHR); weeks 4-7 will consist of exercising for 40 minutes 4 days per week at 70-80% of your MHR; and weeks 7-12 will consist of exercising for 45 minutes 4 days per week at 80-85% MHR
Placebo Comparator: non-exercise
Normal lifestyle routine with no exercise for 12 weeks.
Behavioral: Non exercise
subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 20-50
  • No regular exercise for past 2 years

Exclusion Criteria:

  • Diabetes, Cardiovascular disease, Pregnant or lactating females,BMI >27
  • Medications that may interfere with carbohydrate metabolism - glucocorticoids, adrenergic agonists, ACE inhibitors, alpha blockers, diuretics, beta blockers, oral contraceptives, HMG CoA reductase inhibitors
  • History of epilepsy, cancer, hepatitis, active infection, active Graves' disease, cystic fibrosis, sickle cell anemia, peripheral vascular disease, cerebrovascular disease, asthma
  • Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial
  • Inability to give informed consent
  • Prior participation in a clinical trial that could potentially alter insulin sensitivity: e.g., use of new insulin sensitizers
  • HIV seropositive
  • Anemia (Hgb < 12 g/dl)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970099

Locations
United States, California
Ucsf Gcrc
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: Ira Goldfine, UCSF
ClinicalTrials.gov Identifier: NCT00970099     History of Changes
Other Study ID Numbers: H6820-22194, 1 R01 DK059358-01A2
Study First Received: August 31, 2009
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on July 26, 2014