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Clinical Trials/ACTRN12617000552381
ACTRN12617000552381
Terminated
未知

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.

The University of Sydney0 sites162 target enrollmentApril 20, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
The University of Sydney
Enrollment
162
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 20, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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