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Exercise Training in Older Diabetic Women

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
University of San Francisco
ClinicalTrials.gov Identifier:
NCT00341614
First received: June 19, 2006
Last updated: August 14, 2007
Last verified: August 2007
History of Changes
  Purpose

Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in particular, have a higher mortality rate for coronary artery disease (CAD) than male diabetics.C-reactive protein measurement in the clinical setting enhances the detection of individuals who are at high risk for cardiovascular disease (CVD), by providing additional predictive value.

We propose to study the effects of a supervised exercise and diet intervention on cardiovascular disease risk in postmenopausal diabetic women. We will recruit 35 postmenopausal, sedentary type 2 diabetics who will undergo a 3 month exercise and dietary intervention. They will exercise 3 times a week for 30 min in a supervised setting. Exercise mode will be aerobic and self-selected (i.e. treadmill, bike) at an intensity level of 50-85% VO2peak. Blood glucose will be monitored before and after exercise. The dietary intervention will consist of 6 meetings with a registered dietitian.

The study is designed to test the following hypotheses:

  • Cardiovascular disease risk measures will be different following a 3-month exercise and diet intervention.

    • H1: Blood markers for coronary artery disease risk, as measured by CRP, TC, LDL, TG, FG, fasting insulin, and HbA1c, will be different following a 3-month exercise and diet intervention.
    • H2: Anthropometric measures of coronary artery disease risk, as measured by WHR, will be different following a 3-month exercise and diet intervention.
    • H3: Resting blood pressure, as measured by SBP and DBP, will be different following a 3-month exercise and diet intervention.
    • H4: Total body fat, as measured by DXA, will be different following a 3-month exercise and diet intervention.

  • Health-related measures will be different following a 3-month exercise and diet intervention.

    • H1: Cardiorespiratory fitness, as measured by maximal oxygen consumption (VO2max) will be different following a 3-month exercise and diet intervention.
    • H2: Bone-mineral density, as measured by DXA, will be different following a 3-month exercise and diet intervention.
    • H3: Dietary measures (total daily kcal, and daily fat kcal) will be different following a 3-month exercise and diet intervention.

Condition Intervention Phase
Cardiovascular Diseases
Diabetes Mellitus, Type 2
 Behavioral: 3-month Exercise Training and Diet Education
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of an Exercise and Diet Intervention on Cardiovascular Risk Factors in Postmenopausal Type 2 Diabetics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of San Francisco:

Primary Outcome Measures:
  • VO2max at 3 months [ Time Frame: 3 months ]
  • C-reactive protein at 3 months [ Time Frame: 3 months ]
  • Blood lipids (total cholesterol, LDL, HDL, TC/HDL ratio, triglycerides) at 3 months [ Time Frame: 3 months ]
  • Fasting glucose at 3 months [ Time Frame: 3 months ]
  • Fasting insulin (insulin resistance) at 3 months [ Time Frame: 3 months ]
  • HbA1C at 3 months [ Time Frame: 3 months ]
  • Body fat % at 3 months [ Time Frame: 3 months ]
  • Blood pressure (SBP, DBP) at 3 months [ Time Frame: 3 months ]
  • Waist-hip ratio at 3 months [ Time Frame: 3 months ]
  • Total kcal and fat kcal at 3 months [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Bone-mineral density at 3 months [ Time Frame: 3 months ]

Estimated Enrollment: 35
Study Start Date: June 2006
Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female 45-75 yrs old
  • Type 2 diabetic for > 6 months

  • "Reasonable" control of diabetes

    • blood glucose within 100-250 mg/dl prior to exercise
    • absence of hypoglycemic symptoms
    • diabetes control verified by physician
    • cleared by physician to begin exercise program
  • Postmenopausal > 6 months
  • Sedentary
  • Ability and willingness of patient to give written, informed consent
  • Able and willing to participate in an exercise intervention

Exclusion Criteria:

  • Diabetes not in control

    • unable to maintain blood glucose within 100-250 mg/dl
    • development of urinary ketone bodies (ketosis)
    • symptoms of hypoglycemia before, during, and post-exercise
    • no physician's approval to participate
  • Male
  • Female <45 or >75 yr
  • > 300 lb (weight limit for DXA table)
  • On insulin
  • Contraindications to Exercise Testing (ACSM, 2000)
  • Ischemia
  • Recent myocardial infarction
  • Unstable angina
  • Uncontrolled cardiac arrhythmias
  • Severe aortic stenosis
  • Uncontrolled heart failure
  • Acute pulmonary embolus
  • Acute myocarditis or pericarditis
  • Dissecting aneurysm
  • Acute infections
  • Electrolyte abnormalities
  • Severe hypertension (SBP > 200 mm Hg, DBP > 110 mm Hg at rest)
  • Tachyarrhythmias or bradyarrhythmias
  • Hypertrophic cardiomyopathy
  • Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise
  • Not able to complete exercise testing (i.e must be ambulatory and without orthopedic limitations which would preclude maximal effort exercise)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00341614

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of San Francisco
University of California, San Francisco
Investigators
Principal Investigator: Deborah Sellmeyer, M.D. University of California, San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00341614     History of Changes
Other Study ID Numbers: FDF-05-06
Study First Received: June 19, 2006
Last Updated: August 14, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of San Francisco:
Exercise
Diabetes Mellitus, Type 2
Postmenopause
Diet

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013