Type 2 Diabetes and Exercise - A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00666861
Recruitment Status : Terminated (Pilot study superseded by a larger NHMRC funded trial)
First Posted : April 25, 2008
Last Update Posted : July 30, 2009
International Diabetes Institute, Australia
Baker Heart Research Institute
Information provided by:
Bayside Health

Brief Summary:

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 or disease
Type 2 Diabetes

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).

Study Type : Observational
Actual Enrollment : 2 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
Plasma samples

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type 2 Diabetes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00666861

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

Responsible Party: Assoc/Prof Bronwyn Kingwell - Executive Director Science Policy and Head, Clinical Physiology, Baker Heart Research Institute Identifier: NCT00666861     History of Changes
Other Study ID Numbers: 290/07
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009

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