Type 2 DiabetesNCT00666861
Type 2 Diabetes and Exercise - A Pilot Study
An observational study of Type 2 Diabetes, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 2 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2008to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type 2 Diabetes
Who may be able to join
- Diet controlled Diabetes
- Overweight (BMI > 27 kg/m2 but <50 kg/m2)
Who cannot join
- Hypoglycaemic Agents
- Lipid Lowering Agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study
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:
- Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.
- 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.
Read the 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).
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionNov 2008
Why it stopped: Pilot study superseded by a larger NHMRC funded trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- International Diabetes Institute, Australia, Baker Heart Research Institute
- Investigators
- Bronwyn A Kingwell, PhD, Principal investigator, Baker Heart Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666861
- Sponsor's protocol ID
- 290/07
- Status last verified
- Jul 2009
- First submitted
- 23 Apr 2008
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study
- ClinicalTrials.gov ID
- NCT00666861
- Acronym / sponsor ID
- 290/07
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Pilot study superseded by a larger NHMRC funded trial
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- International Diabetes Institute, Australia, Baker Heart Research Institute
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 Diabetes
Key inclusion criteria (2 listed)
- Diet controlled Diabetes
- Overweight (BMI > 27 kg/m2 but <50 kg/m2)
Key exclusion criteria (2 listed)
- Hypoglycaemic Agents
- Lipid Lowering Agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Pilot study superseded by a larger NHMRC funded trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronwyn A Kingwell, PhD principal investigator
Baker Heart Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Pilot study superseded by a larger NHMRC funded trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2009.