Mechanism of Insulin-Resistant in Lean Non-Diabetics

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Completed
Phase 1

Conditions

Insulin Resistance
Type 2 Diabetes
Insulin Sensitivity

Treatments

Behavioral: exercise
Behavioral: Non exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00970099
1R01DK059358-01A2 (U.S. NIH Grant/Contract)
H6820-22194

Details and patient eligibility

About

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.

Enrollment

149 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

149 participants in 2 patient groups, including a placebo group

Exercise
Active Comparator group
Description:
12 week exercise regimen
Treatment:
Behavioral: exercise
non-exercise
Placebo Comparator group
Description:
Normal lifestyle routine with no exercise for 12 weeks.
Treatment:
Behavioral: Non exercise

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems