Status:
COMPLETED
Dance Dance Revolution (DDR) in Type 2 Diabetes
Lead Sponsor:
Charles Drew University of Medicine and Science
Collaborating Sponsors:
American Diabetes Association
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Regular physical activity is important for the treatment of type 2 diabetes, but it is often not sustained for many reasons, including lack of interest. New video games that involve physical movement ...
Detailed Description
This study is a randomized, controlled trial of a 3-month ad libitum program of the "exergame" "Dance Dance Revolution" (DDR) versus traditional treadmill exercise. Each group of subjects will be asse...
Eligibility Criteria
Inclusion
- Age 18 to 65 inclusive
- Diagnosed type 2 diabetes mellitus (by ADA diagnostic criteria) for at least 1 year
- On stable doses of oral anti-hyperglycemic medications for at least 3 months (i.e., sulfonylureas, metformin, thiazolidinediones, and/or DPP-4 inhibitors; GLP-1 analogues may also be permitted)
- Hemoglobin A1c level between 7.5% and 9.0% inclusive
- Body mass index (BMI) between 25.0 and 40.0 kg/m2 inclusive
- Able to engage in a regular program of mild-to-moderate intensity physical activity
- Subjects not currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.)
- Able to give informed consent and cooperate with all necessary procedures of the study
Exclusion
- Any contraindications to a regular program of mild-to-moderate intensity exercise, or any cardiovascular, pulmonary, orthopedic, rheumatological or neurological conditions that may, in the opinion of the investigators, interfere with the subject's optimal participation in a regular exercise program, interfere with the quality of the data collected from the subject, or make a regular exercise program potentially hazardous
- Diabetes mellitus currently being treated with insulin and/or pramlintide
- Screening fasting plasma glucose (FPG) 300 mg/dL or greater or symptoms of hyperglycemia (polyuria, polydipsia); screening FPG \< 60 mg dL, or a history of symptomatic hypoglycemia averaging more than once per day; or any other history suggestive of erratic glucose control
- Screening fasting triglycerides 500 mg/dL or greater; or LDL-cholesterol 200 mg/dL or greater; screening blood pressure averaging 180 mm Hg or greater systolic or 100 mm Hg or greater diastolic
- Subjects currently engaged in any regimented exercise program outside of the usual activities of daily living that is intended to achieve metabolic changes (e.g., weight loss, athletic training, etc.); any such activities occurring on a sporadic basis may still disqualify the subject, depending upon its frequency, to be judged at the discretion of the PI. Subjects must maintain their usual occupational and other routine daily activities during the study at a reasonably constant level.
- Subjects who routinely engage in DDR, either at home or video game arcades; "occasional" participation in DDR may still disqualify the subject, depending upon the frequency of participation, to be judged at the discretion of the PI
- Changing doses of any concurrent medications that are known to alter the study's outcomes (e.g., oral anti-hyperglycemic agents, lipid-lowering agents, weight loss agents, anti-hypertensive agents, systemic glucocorticoids, thyroid medications, hormone replacement therapies, oral contraceptives, etc.) or the anticipated need to start any of these medications; such medications taken concurrently must remain at constant dosages throughout the study.
- Past history of clinically significant dysfunction of other organ systems (e.g., known hepatic disease or hepatic transaminase levels greater than 3X the upper limit of the normal range other than steatohepatitis; known renal dysfunction or creatinine level 1.5 mg/dL or greater; past history of malignancies excluding cutaneous basal cell carcinoma; known chronic infections including HIV, endocrinopathies such as untreated thyroid disease, adrenal disease, or pituitary dysfunction, etc.), or any recent surgeries that preclude regular exercise, in the opinion of the investigators
- Active hemolytic anemia, known hemoglobinopathies, or any other state of accelerated RBC turnover that may alter the accuracy of the HbA1c measurement
- Pregnancy or lactation
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00851019
Start Date
February 1 2009
End Date
July 1 2012
Last Update
March 27 2013
Active Locations (1)
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1
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059