Type 2 Diabetes and Exercise - A Pilot Study

NCT ID: NCT00666861

Last Updated: 2009-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Diabetes Institute, Australia

OTHER

Sponsor Role collaborator

Baker Heart Research Institute

OTHER

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Baker Heart Research Institute

Principal Investigators

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Bronwyn A Kingwell, PhD

Role: PRINCIPAL_INVESTIGATOR

Baker Heart Research Institute

Locations

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Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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290/07

Identifier Type: -

Identifier Source: org_study_id