NCT00970099

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

August 31, 2009

Last Update Submit

January 22, 2014

Conditions

Insulin ResistanceInsulin SensitivityType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity and insulin signaling

    12 weeks

Study Arms (2)

Exercise

ACTIVE COMPARATOR

12 week exercise regimen

Behavioral: exercise

non-exercise

PLACEBO COMPARATOR

Normal lifestyle routine with no exercise for 12 weeks.

Behavioral: Non exercise

Interventions

exerciseBEHAVIORAL

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

Exercise
Non exerciseBEHAVIORAL

subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist

non-exercise

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ucsf Gcrc

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 2, 2009

Study Start

February 1, 2004

Primary Completion

March 1, 2007

Study Completion

December 1, 2009

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

US(1)