Cognition and Type 2 Diabetes – A pilot randomised controlled trial (RCT) of exercise

Not Applicable

Completed

• Conditions: Metabolic and Endocrine - Diabetes; dementia; Neurological - Dementias; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; cognitive impairment; type 2 diabetes

• Registration Number: ACTRN12614000222640
• Lead Sponsor: Dr Michele Callisaya

Brief Summary

Type 2 Diabetes (T2D) is associated with increased risk of dementia. We aimed to determine the feasibility of a randomised controlled trial (RCT) examining the efficacy of exercise on brain health in people with T2D. Methods: A 6-month pilot RCT of a progressive aerobic- and resistance-training program versus a gentle movement control group in people with T2D aged 50–75 years (n = 50). Brain volume (total, white matter, hippocampus), cortical thickness and white matter microstructure (fractional anisotrophy and mean diffusivity) were measured using magnetic resonance imaging, and cognition using a battery of neuropsychological tests. Study design was assessed by any changes (during the pilot or recommended) to the protocol, recruitment by numbers screened and time to enrol 50 participants; randomisation by similarity of characteristics in groups at baseline, adherence by exercise class attendance; safety and retention by numbers withdrawn. Results: A total of 114 people were screened for eligibility, with 50 participants with T2D enrolled over 8 months. 47 participants (94%) completed the study (23 of 24 controls; 24 of 26 in the intervention group). Exercise class attendance was 79% for the intervention and 75% for the control group. This study supports the feasibility of a larger definitive trial.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-03
• Study Completion: 2015-12-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria
1) T2DM as diagnosed by fasting blood glucose greater or equal to 7 mmol/L or HbA1C greater than 6.4 % or 2 hr post-prandial glucose greater than 11 mmol/L according to current American Diabetes Association Guidelines.
2) Age 50-75 years
3) Be willing and able to participate in a structured exercise program for 6-months.

Exclusion Criteria

1) any severe medical condition that precludes safe participation in exercise;
2) moderate or severe dementia
3)Known central nervous system disorders that may have confounding effects on cognitive function (e.g. tumour, multiple sclerosis, Parkinsons disease)
4)contra-indication to MRI;
5) exercising greater than the equivalent of 30 minutes once a week in the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain MRI - grey matter volume[baseline and 6 months]