Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00458133
Eligibility Criteria:
Inclusion Criteria:
* Age 30-75 years
* type 2 diabetes determined by self-report with verification
* 6.5% \< HbA1C \< 11%
* sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise
Exclusion Criteria:
* inadequate control of co-morbid conditions
* resting blood pressure greater than or equal to 160/100 mm Hg
* Triglycerides greater than or equal to 500 mg/dL
* BMI is greater than or equal to 48
* current use of an insulin pump or insulin injections other than Lantus
* metal object in the body that may interfere with MRI/MRS scans
* factors that may limit adherence to intervention or affect conduct of the trial
1. unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
2. failure to complete behavioral run-in and baseline testing
3. hospitalization for depression in the last 6 months
4. not physically capable of performing the exercise required for the study protocols
5. consuming \> 14 alcoholic beverages per week
6. plans to be away \> 4 weeks in the next 9 months
7. lack of support from primary health care provider or family members
8. significant weight loss in the past year (\>20 lbs) or current use of weight loss medications
9. current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
10. another member of household is a participant or staff member of HART-D
11. bariatric surgery
12. other temporary intervening event, such as sick spouse, bereavement, or recent move
13. other medical, psychiatric, or behavioral limitations that, in the view of the principal investigator, may interfere with study participation or the ability to follow the intervention protocol
* underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
1. pregnant or plan on becoming pregnant in the next 9 months
2. cancers requiring treatment in the past 5 years, unless prognosis is excellent
3. self-reported HIV or tuberculosis
4. history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
5. renal disease: urine dipstick 4+ protein, serum creatinine is greater than or equal to 1.4 mg/dL (women) or is greater than or equal to 1.5 mg/dL (men) or currently receiving dialysis
6. any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
7. advanced neuropathy or retinopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00458133
Study Brief:
Protocol Section:
NCT00458133