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

In people with type 2 diabetes, does structured exercise improve or preserve brain health?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000222640
Acronym
CDOT-X
Enrollment
50
Registered
2014-03-03
Start date
2014-06-26
Completion date
2015-05-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 2 Diabetes (T2DM) is a significant risk factor for dementia in older people, and vascular disease may underlie this relationship. Greater physical activity is associated with better brain function and is also recommended for people with T2DM to reduce cardiovascular risk. However, it is currently unknown as to whether an exercise intervention can preserve or improve brain health in people with T2DM. The aim of this project is to examine the efficacy of a six month structured exercise program in preserving brain health in late middle aged people with T2DM, and evaluate whether this occurs by improving vascular health. This will be done by using MRI scans to measure brain perfusion and structure, sophisticated measures of large and small artery health, and cognitive function before and after the intervention.

Interventions

The intervention group will receive a 6 month structured exercise program by fully trained exercise physiologists. Two one-hour supervised sessions per week will occur at the Menzies Research Institute gymnasium on non-consecutive days, plus a further one-hour per week unsupervised session at the participant’s home with prescribed exercises (e.g. walking). Each supervised session will consist of a warm-up and cool-down, moderate- to high-intensity progressive resistance training exercises using

The intervention group will receive a 6 month structured exercise program by fully trained exercise physiologists. Two one-hour supervised sessions per week will occur at the Menzies Research Institute gymnasium on non-consecutive days, plus a further one-hour per week unsupervised session at the participant’s home with prescribed exercises (e.g. walking). Each supervised session will consist of a warm-up and cool-down, moderate- to high-intensity progressive resistance training exercises using body weight, simple machine or free weights of 8-15 repetitions (e.g. free weights: bicep curls, shoulder press, chest press; body weight: step ups or sit to stand +/- weight vest; machine weights: quadriceps press, shoulder press, chest press, knee extension), and an aerobic component involving stationary cycling, cross trainer or treadmill walking at 40-84% of VO2R. The program will be tailored to participant’s abilities and progressive intensity applied with increasing fitness. Adherence will be assessed by attendance at the supervised exercise sessions and completion of personal exercise diaries.

Sponsors

Dr Michele Callisaya
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026