NCT00851019

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 ("exergames") may help in this regard. This study will compare the "exergame" "Dance Dance Revolution" (DDR) with traditional treadmill exercise on blood sugar control among sedentary, overweight or obese adults with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable type-2-diabetes-mellitus

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, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 27, 2013

Status Verified

March 1, 2013

Enrollment Period

3.4 years

First QC Date

February 23, 2009

Last Update Submit

March 25, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

ExerciseVideo gameType 2 diabetesDance

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c change from baseline

    3 months

Secondary Outcomes (12)

  • Body mass index change from baseline

    3 months

  • Body composition change from baseline

    3 months

  • Fasting lipid profile change from baseline

    3 months

  • Blood pressure change from baseline

    3 months

  • Fasting plasma glucose change from baseline

    3 months

  • +7 more secondary outcomes

Study Arms (2)

DDR

EXPERIMENTAL

"Dance Dance Revolution" (DDR) Exergaming

Behavioral: DDR

Treadmill

ACTIVE COMPARATOR

Treadmill exercise

Behavioral: Treadmill

Interventions

DDRBEHAVIORAL

Ad libitum attendance to engage in "Dance Dance Revolution" (DDR) Exergaming, for a 3-month period

DDR
TreadmillBEHAVIORAL

Ad libitum attendance to engage in treadmill exercise, for a 3-month period

Treadmill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Stanley Hsia, MD

    Charles Drew University of Medicine and Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 27, 2013

Record last verified: 2013-03

Locations

US(1)