Type 2 Diabetes and Exercise - A Pilot Study

This study has been terminated.
(Pilot study superseded by a larger NHMRC funded trial)
Sponsor:
Collaborators:
International Diabetes Institute, Australia
Baker Heart Research Institute
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00666861
First received: April 23, 2008
Last updated: July 28, 2009
Last verified: July 2009
  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:

  1. Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.
  2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour (sitting) on glucose and triglyceride concentrations and key muscle and adipose regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent bouts of light-intensity activity.

Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Biospecimen Retention:   Samples Without DNA

Plasma samples


Enrollment: 2
Study Start Date: April 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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
Study Population

Patients with Type 2 Diabetes

Criteria

Inclusion Criteria:

  1. Diet controlled Diabetes
  2. Overweight (BMI > 27 kg/m2 but <50 kg/m2)

Exclusion Criteria:

  1. Hypoglycaemic Agents
  2. Lipid Lowering Agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666861

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
International Diabetes Institute, Australia
Baker Heart Research Institute
Investigators
Principal Investigator: Bronwyn A Kingwell, PhD Baker Heart Research Institute
  More Information

No publications provided

Responsible Party: Assoc/Prof Bronwyn Kingwell - Executive Director Science Policy and Head, Clinical Physiology, Baker Heart Research Institute
ClinicalTrials.gov Identifier: NCT00666861     History of Changes
Other Study ID Numbers: 290/07
Study First Received: April 23, 2008
Last Updated: July 28, 2009
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014