Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-03 @ 10:12 PM
Study NCT ID:
NCT00666861
Status:
TERMINATED
Last Update Posted:
2009-07-30
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 2 Diabetes and Exercise - A Pilot Study
Sponsor:
Bayside Health
Organization:
Study Overview
Official Title:
Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pilot study superseded by a larger NHMRC funded trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: