Health benefits of a novel exercise intervention in Type 2 diabetes

Completed

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN02750650
• Lead Sponsor: niversity of Bath (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

1. Men aged =40 years and =60 years
2. Diagnosed with Type 2 diabetes according to WHO criteria at least 6 months prior to entering the study: fasting plasma glucose = 7.0 mmol/l (126 mg/dl) - OR 2-hour plasma glucose sample in a standard OGTT of =11.1 mmol/l (200 mg/dl)

Exclusion Criteria

1. Insulin therapy
2. Use of sulphonylureas
3. Use of more than two anti-diabetic drugs
4. Use of ß-blockers
5. Use of inhaled steroids (e.g., for asthma)
6. Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension treated with no more than two drugs (either an ACE, ARB, calcium channel blocker or diuretic)
7. Cerebrovascular disease including previous stroke or aneurysm
8. History of exercise-induced asthma
9. History of Type 1 diabetes mellitus or a history of ketoacidosis
10. History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant)
11. Any prior history of malignancy with the exception of:
11.1. Basal cell carcinoma of the skin
11.2. Squamous cell carcinoma of the skin that has been recurrence-free for 5 years
11.3. Other malignancies (regardless of site) that have been recurrence-free for 5-10 years
12. BMI >35 kg/m2
13. Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg after at least a 5-minute seated rest at the screening visit)
14. A clinically significant ECG abnormality at the screening visit which in the opinion of the investigators exposes the subject to risk by enrolling in the trial
15. Overt contraindications to exercise as determined with a normal resting ECG
16. ?Yes? to any questions on a standard physical activity readiness questionnaire (PAR-Q)
17. Classification as highly physically active on the International Physical Activity Questionnaire (IPAQ)
18. Current participation in another research study
19. Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control; timepoint(s): pre and post both interventions

Secondary Outcome Measures

Name	Time	Method
1. Aerobic fitness; timepoint(s): pre and post both interventions<br>2. Body composition; timepoint(s): pre and post both interventions