EXERFLOW STUDY:The effects of aerobic and resistance exercise training on vascular endothelial function in people with type 2 diabetes mellitus

Not Applicable

Completed

• Conditions: Type 2 diabetes; Vascular function (endothelial function); Metabolic and Endocrine - Diabetes; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12609000799257
• Lead Sponsor: Baker IDI Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

People with established type 2 diabetes (duration > 6 months), treated with diet or oral antihyperglycaemic agents, as monotherapy, dual or triple therapy with metformin, sitagliptin, glitazone or acarbose; (no more than 3 oral agents; stable dose for = 8 weeks), with stable weight over the previous 3 months (< 5% change in body weight), stable glycaemic control for at least the past 8 weeks (no changes to diabetes medication), HbA1c greater or equal to 6.5% and less than or equal to 9.9%.

Exclusion Criteria

Exceeding the national recommendations for exercise which are at least 30 mins of moderate-intensity aerobic activity on 5 days of the weeks for at least 3 months and/or at least 20 mins of vigorous-intensity aerobic activity on 3 days of the week for at least 3 mths (60 mins per week). Any strength trainig for 2 or more sessions per week in last 3 months is an exclusion. Body mass index <18.0 or >40.0, seated resting blood pressure > 160 mm Hg systolic of > 95 mm Hg diastolic, pregnancy, anticipated requirement for medications affecting glucose tolerance during trial, renal disease or kidney failure, current smoker, taking medication to lower heart rate (beta blockers), unable to commit to completing the entire protocol, language other than English, known physical activity contraindications, other illness/injury (acute or chronic) leading to physical or medical problems that may limit the ability to perfom the necessary exercise.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow mediated dilatation of the brachial artery, assessed by ultrasound measurement of brachial artery diameter change and image analysis software[Baseline and after completion of 8 weeks of training sessions.]

Secondary Outcome Measures

Name	Time	Method
C reactive protein, assessed by blood analysis[Baseline and at 48 hrs (2 days), 96 hrs (4 days), 168 hrs (7 days) after final training session];Fasting plasma glucose[Baseline and at 48 hrs (2 days), 96 hrs (4 days), 168 hrs (7 days) after final training session];Glycated haemoglobin (HbA1c), assessed by blood analysis[Baseline and after completion of 8 weeks of training sessions.];Lipids [total cholesterol, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), triglycerides], assessed by blood analysis[Baseline and after completion of 8 weeks of training sessions.];Serum insulin[Baseline and at 48 hrs (2 days), 96 hrs (4 days), 168 hrs (7 days) after final training session]