Status:
COMPLETED
Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training alone (RT), resistance ...
Detailed Description
Although it is generally accepted that regular exercise provides substantial health benefits to individuals with T2D, the exact exercise prescription in terms of type (AT versus RT versus AT+RT) still...
Eligibility Criteria
Inclusion
- Age 30-75 years
- type 2 diabetes determined by self-report with verification
- 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
- 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
- unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
- failure to complete behavioral run-in and baseline testing
- hospitalization for depression in the last 6 months
- not physically capable of performing the exercise required for the study protocols
- consuming \> 14 alcoholic beverages per week
- plans to be away \> 4 weeks in the next 9 months
- lack of support from primary health care provider or family members
- significant weight loss in the past year (\>20 lbs) or current use of weight loss medications
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- another member of household is a participant or staff member of HART-D
- bariatric surgery
- other temporary intervening event, such as sick spouse, bereavement, or recent move
- 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
- pregnant or plan on becoming pregnant in the next 9 months
- cancers requiring treatment in the past 5 years, unless prognosis is excellent
- self-reported HIV or tuberculosis
- history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
- 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
- any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
- advanced neuropathy or retinopathy
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00458133
Start Date
April 1 2007
End Date
June 1 2010
Last Update
September 15 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70817