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Diabetes Aerobic and Resistance Exercise (DARE) Study
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Ottawa Health Research Institute
Canadian Institutes of Health Research (CIHR)
University of Ottawa
Canadian Diabetes Association
Information provided by: Ottawa Health Research Institute
ClinicalTrials.gov Identifier: NCT00195884
  Purpose

The main purpose of this study is to assess the impact of exercise training (aerobic exercise, resistance exercise, combined aerobic and resistance exercise) versus a sedentary waiting list control on glycemic control (as reflected in reduced hemoglobin A1c [HbA1c]), body composition (weight, body mass index [BMI], waist circumference, total body fat, visceral and subcutaneous abdominal fat, mid-thigh muscle cross-sectional area), lipids (Apo-B, Apo-A1, Apo-B/A1 ratio, low density lipoprotein (LDL) particle diameter, high-sensitivity C-reactive protein) and quality of life.


Condition Intervention
Diabetes Mellitus, Type 2
Diabetes Mellitus
Behavioral: Aerobic and Resistance Exercise

MedlinePlus related topics: Diabetes Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title: Resistance Exercise as an Intervention in Type 2 Diabetes Mellitus

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:
  • hemoglobin A1c (HbA1c)

Secondary Outcome Measures:
  • Body composition (CT scan)
  • resting energy expenditure
  • LDL particle diameter
  • plasma insulin
  • apoprotein B
  • c-reactive protein
  • free fatty acids
  • HDL-C
  • LDL-C
  • triglycerides
  • total/HDL cholesterol ratio
  • Blood Pressure
  • quality of life (QOL)

Estimated Enrollment: 216
Study Start Date: September 1999
Estimated Study Completion Date: April 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus as defined by the 1998 CDA Guidelines
  • Male or female
  • treated with diet and/or oral agents (no insulin)
  • age 40-70
  • HbA1c 0.066-0.099

Exclusion Criteria:

  • Participation during the previous 6 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training during the previous 6 months
  • Insulin therapy, or uncontrolled hyperglycemia (HbA1c>0.099). Insulin therapy is an exclusion criterion because it would render HOMA insulin sensitivity calculation invalid.
  • Changes in medications for diabetes, BP or lipids in the 2 months prior to enrollment.
  • Significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
  • Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria >1 g/24 hours.
  • Uncontrolled hypertension: BP >160 mm Hg systolic or >95 mm Hg diastolic BP in a sitting position.
  • Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
  • Other illness, judged by the patient or study physician to make participation in this study inadvisable.
  • Significant cognitive deficit resulting in inability to understand or comply with instructions.
  • Pregnancy at the start of the study, or intention to become pregnant in the next year.
  • Inability to communicate in English or French.
  • Unwillingness to sign informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195884

Locations
Canada, Ontario
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Health Research Institute
Canadian Institutes of Health Research (CIHR)
University of Ottawa
Canadian Diabetes Association
Investigators
Principal Investigator: Ronald J Sigal, MD MPH FRCPC Ottawa Health Research Institute, Ottawa Hospital, University of Ottawa
  More Information

Publications:
Publications indexed to this study:
Study ID Numbers: MCT-44155
Study First Received: September 12, 2005
Last Updated: September 23, 2006
ClinicalTrials.gov Identifier: NCT00195884  
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:
Diabetes Mellitus
Type 2 Diabetes
Aerobic
Resistance
weight training
Exercise

Study placed in the following topic categories:
Body Weight
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009