Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 diabetes Cohorts in China and Australia.

Not Applicable

• Conditions: on-alcoholic fatty liver disease; Type 2 Diabetes Mellitus; Pre-diabetes; Non-alcoholic fatty liver disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000552381
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-20
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

BMI greater than or equal to 25 kg/m2 (Non-Asian participants) or BMI greater than or equal to 23 kg/m2 (Asian participants)
- Willing to undertake, and have no contraindications to, exercise testing and a program involving high intensity interval training program, resistance training or stretching
- Willing to give written informed consent
- Adequate understanding of national language
- Access to either phone or internet (this is necessary when being contacted by the instructors throughout the duration of the trial)
- Maximum weight of 140kg (equivalent MRI habitus limit)
- No change in medication or dose for the previous three months

- 90 participants at each site will be recruited from each of three glucose groups as defined by any one of the ADA criteria. That is Type 2 Diabetes Mellitus - HbA1c greater than or equal to 6.5%, Fasting Plasma Glucose (FPG) greater than or equal to 7.0 mmol/L, 2h post-Oral Glucose Tolerance Test Plasma Glucose (2hOGTT) greater than or equal to 11.1 mmol/L; Pre-diabetes - one occasion of any of the following in a participants medical history: HBA1c greater than or equal to 5.7% but less than 6.5%, FPG greater than or equal to 5.6 mmol/L but less than 7.0 mmol/L, 2hOGTT greater than or equal to 7.8 mmol/L but less than 11.1 mmol/L; Normal Glucose Profile - HbA1c less than 5.7%; FPG less than 5.6%; 2hOGTT less than 5.6 mmol/L.

Exclusion Criteria

- Untreated dense insensate peripheral neuropathy that contraindicates exercise testing and training (as assessed by medical assessment)
- Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease
- Active foot ulcer
- Musculoskeletal condition affecting ability to undertake exercise testing and training
- Self-reported average weekly intake of alcohol >140g per week
- Abnormalities noted by medical officer based on the resting ECG suggestive of unrecognised myocardial ischaemia: q waves, or ST wave depression.
- Self-reported currently completing >75 min/week high intensity exercise or >150 min/week moderate intensity exercise.
- Pregnancy, lactation or plans to become pregnant in the next 2 years.
- Claustrophobia or ferrous metal implants/devices which contraindicate MRI scan.
- Thiazolidinedione medication
- History of Hepatitis B or C which has not been cured
- Advanced chronic renal impairment (CKD state 4 or 5 or EFGR< 30)
- Cirrhosis
- Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed)
- Blood donation or transfusion within the past month
- Haemoglobin concentration below local laboratory reference values (i.e. anaemia).
- Alanine Transaminase (ALT) and/or Apartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values)
- Any other condition deemed by the study physician that would prevent participation in the trial.
- Weight change of greater than or equal to 5% in the past three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified