Dance Dance Revolution (DDR) in Type 2 Diabetes

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 assessed at baseline, and then assigned exclusively to one of the two
exercise modalities. Subjects will be free to attend exercise sessions in their assigned
exercise modality at the exercise facility, at a frequency, duration and intensity of their
own choosing with minimal staff supervision, for a period of exactly 90 days; adoption of
new exercise programs outside of the study will be prohibited. Dosages of any concurrent
medications will be maintained constant, and all subjects will receive standardized
nutrition counseling.

Inclusion Criteria:

- 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 Criteria:

- 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