Assessment of exercise options in newly-diagnosed patients with type 2 diabetes mellitus

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12608000286347
• Lead Sponsor: Centre for Clinical Research & effective practice (CCRep)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in flow-mediated dilation in the brachial artery in the forearm before and after the administration of sub-lingual Glyceryl trinitrate. We will be using a portable ultrasound device (General Electrics ? Logiq e) to make the brachial artery measurements.[At baseline, and after each 8 week exercise intervention (which may include active control)]

Secondary Outcome Measures

Name	Time	Method
Central aortic blood pressure[at baseline, and after each 8 week exercise intervention (which may include active control)];Change in mean brachial blood pressure[At baseline, and after each 8 week exercise intervention (which may include active control)];Change in fasting lipid levels (cholesterol, HDL-c, & triglyceride). This will be assessed using blood samples.[At baseline, and after each 8 week exercise intervention (which may include active control)];Change in urine albumin:creatinine ratio[At baseline, and after each 8 week exercise intervention (which may include active control)];Change in insulin resistance as calculated by homeostasis model assessment of insulin resistance (HOMA-IR).[At baseline, and after each 8 week exercise intervention (which may include active control)];Change in Quality of life as measured by the Short Form 36 (SF-36) Questionnaire.[At baseline, and after each 8 week exercise intervention (which may include active control)]