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(Pilot study superseded by a larger NHMRC funded trial)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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014