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| Sponsors and Collaborators: |
Bayside Health International Diabetes Institute, Australia Baker Heart Research Institute |
|---|---|
| Information provided by: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00666861 |
Purpose
A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight adults with type 2 diabetes the aims of this pilot study are to:
| Condition |
|---|
|
Type 2 Diabetes |
| Study Type: | Observational |
| Study Design: | Cohort, Cross-Sectional |
| Official Title: | Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-Meal Glucose and Lipids - A Pilot Study |
Plasma samples
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2009 |
The proposed study will involve a randomised cross-over experimental trial conducted in the laboratory setting in older overweight adults with type 2 diabetes. Participants will receive both of the acute testing conditions in a randomised manner.
Study design: Randomised cross-over pilot trial of 20 overweight/obese older adults with diet-controlled type 2 diabetes involving 2 acute treatment conditions, with a one-week wash-out period between testing conditions (Figure 1 a).
Setting: Acute, supervised laboratory setting within the Alfred and Baker Heart Institute Medical Unit.
Outcomes: We will measure acute responses in laboratory-measured plasma glucose & triglyceride levels (every 60 mins) and glucose concentrations determined from continuous glucose monitoring (CGMS).
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Type 2 Diabetes
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Miriam M Clayfield | +61-3-9076 2948 | m.clayfield@alfred.org.au |
| Australia, Victoria | |
| Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Miriam M Clayfield +61-3-9076 2948 m.clayfield@alfred.org.au | |
| Principal Investigator: | Bronwyn A Kingwell, PhD | Baker Heart Research Institute |
More Information
| Responsible Party: | Baker Heart Research Institute ( Assoc/Prof Bronwyn Kingwell - Executive Director Science Policy abd Head, Clinical Physiology ) |
| Study ID Numbers: | 290/07 |
| Study First Received: | April 23, 2008 |
| Last Updated: | April 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00666861 |
| Health Authority: | Australia: National Health and Medical Research Council |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
