Exercise Training in Older Diabetic Women

NCT00341614 | Completed Phase 1

• 1 other identifier: FDF-05-06
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Keywords

Exercise; Diabetes Mellitus, Type 2; Postmenopause; Diet

Outcome Measures

Primary Outcomes (10)

• VO2max at 3 months

  3 months

• C-reactive protein at 3 months

  3 months

• Blood lipids (total cholesterol, LDL, HDL, TC/HDL ratio, triglycerides) at 3 months

  3 months

• Fasting glucose at 3 months

  3 months

• Fasting insulin (insulin resistance) at 3 months

  3 months

• HbA1C at 3 months

  3 months

• Body fat % at 3 months

  3 months

• Blood pressure (SBP, DBP) at 3 months

  3 months

• Waist-hip ratio at 3 months

  3 months

• Total kcal and fat kcal at 3 months

  3 months

Secondary Outcomes (1)

• Bone-mineral density at 3 months

  3 months

Interventions

3-month Exercise Training and Diet Education BEHAVIORAL

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of San Francisco: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise; Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Deborah Sellmeyer, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: August 16, 2007

Record last verified: 2007-08

Locations

US (1)