None listed
Conditions
Brief summary
Type 2 diabetes mellitus has become a significant health problem worldwide, and Counties-Manukau has a disproportionately high prevalence of diabetic people compared to other regions in New Zealand. This is because of the high proportion of Maori and Pacific people who are genetically susceptible, more likely to be obese, and less likely to exercise. Compared with non-diabetic individuals, type 2 diabetic patients have a 3-4 fold increased risk of macrovascular disease and often succumb to coronary artery disease and stroke. Treatment of diabetes based solely on dietary and pharmacologic interventions is difficult and often fails. It is well recognised that some increase in regular exercise is essential to deliver long-term weight reduction and to meet management targets for glucose, lipid and blood pressure control. Yet, recent research studies give confusing and sometimes contradictory messages about the optimal frequency and intensity of exercise. The aim of the current study is to investigate whether a regular intensive supervised circuit training regimen will provide better vascular outcomes compared with the standard exercise advice provided in the New Zealand Type 2 Diabetes Guideline (2002) in a group of newly-diagnosed type 2 diabetic subjects.
Interventions
Comparing intensive exercise regime (physiotherapy led sessions – 3x 1hr per week) with standard guideline exercise (self led 30 minutes of moderate exertion on most days per week).
Total duration of study is 22 weeks (once 32 subjects have been recruited)
There will be 2 weeks between crossing over.
Sponsors
Centre for Clinical Research & effective practice (CCRep)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
Patients to be included in this protocol must: 1. Be aged >30 years and =60 years 2. Have type 2 diabetes mellitus (maximum of 2 years since diagnosis) in accordance with American Diabetes Association criteria treated with diet or metformin oral hypoglycemic medication with an HbA1c 6.5-10% at baseline. 3. Provide written informed consent to participate in the study
Exclusion criteria
A patient with any of the following conditions prior to randomisation will not be enrolled into the study: 1. Diabetic nephropathy (urine albumin creatinine ratio (ACR) >200mg/mmol) 2. Known non-diabetic renal disease as indicated by haematuria, active urinary sediment or casts 3. Serum creatinine >150 µmol/L in men and ?130 µmmol/L in women 4. Morbid obesity with body mass >160kg 5. Abnormal baseline Electrocardiogram (ECG), or inducible ischaemic changes on baseline exercise tolerance test 6. Pregnant, nursing a child, or planning a pregnancy at the time of this study 7. History of type 1 diabetes defined as age of onset <20 years and/or history of continuous treatment with insulin since diagnosis 8. History of cigarette smoking, drug or alcohol abuse 9. Co-morbid conditions that are likely t o affect ability to participate in an exercise program: a. Severe chronic obstructive pulmonary disease (COPD) as evidenced by hospitalization for decompensation within 6 months of randomization, chronic treatment with oral steroids, or a resting oxygen saturation (SAO2) <90 mm Hg b. Congestive heart failure (CHF) corresponding with New York Heart Association (NYHA) Class II, III and IV or an N-terminal pro-brain natriuretic peptide (NT-proBNP) level >350 c. Severe ischaemic heart disease (IHD) with acute coronary event, and/or coronary artery bypass graft (CABG), and/or percutaneous coronary intervention (PCI) in the previous 60 days. d. Severe peripheral vascular disease e. Severe arthritic disease of the feet, knees, hips, or lower spine f. Severe liver disease with icterus and plasma bilirubin =60 µmmol/L, plasma transaminase = 3-fold upper limit of normal, albumin <30 g/L or coagulopathy g. Hematological disorders including hemoglobin <110 g/L or platelet count < 80,000/mm3 10. Gastrointestinal bleeding in the previous 60 days, 11. Malignancy other than basal cell carcinoma. 12. Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.
Outcome results
None listed