Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes (CGMSexercise)
Primary Purpose
Diabetes Mellitus, Type 2, Treatment, Exercise
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acute aerobic exercise
Acute aerobic-resistance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, Exercise, Endurance, Resistance, Continuous glucose monitoring system
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetic patients treated with diet and metformin, 35-65 years old
Exclusion Criteria:
- Type 1 diabetic patients
- Treatment with insulin or sulphonylureas or glitazones
- Proliferative retinopathy
- Severe autonomic neuropathy
- Coronary artery disease
- Baseline fasting plasma glucose>200 mg/dl
- Peripheral artery disease
- Amputation
- Heart failure
- Diabetic nephropathy
- Renal failure
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aerobic exercise
Aerobic-resistance exercise
Arm Description
One bout of aerobic physical training will be performed on a cycle ergometer for 50 min
One bout of aerobic-resistance physical training will be performed on a cycle ergometer added by a strenght training for 50 min (total)
Outcomes
Primary Outcome Measures
Reduction of the prevalence of hyperglycemic peaks during a 24-h period after a bout of aerobic or aerobic/resistance exercise in type 2 diabetes patients on metformin/diet therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT00887094
First Posted
April 22, 2009
Last Updated
August 3, 2011
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00887094
Brief Title
Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes
Acronym
CGMSexercise
Official Title
Acute and Subacute Effects of Aerobic Training vs Aerobic/Resistance Training Upon Glucose Profile Evaluated Through Continuous Glucose Monitoring System in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.
Detailed Description
Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Treatment, Exercise
Keywords
Diabetes mellitus, Exercise, Endurance, Resistance, Continuous glucose monitoring system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
One bout of aerobic physical training will be performed on a cycle ergometer for 50 min
Arm Title
Aerobic-resistance exercise
Arm Type
Experimental
Arm Description
One bout of aerobic-resistance physical training will be performed on a cycle ergometer added by a strenght training for 50 min (total)
Intervention Type
Behavioral
Intervention Name(s)
Acute aerobic exercise
Other Intervention Name(s)
There are no other names
Intervention Description
Aerobic exercise (on a cycle ergometer, for 50 min)
Intervention Type
Behavioral
Intervention Name(s)
Acute aerobic-resistance exercise
Other Intervention Name(s)
There are no other names
Intervention Description
Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)
Primary Outcome Measure Information:
Title
Reduction of the prevalence of hyperglycemic peaks during a 24-h period after a bout of aerobic or aerobic/resistance exercise in type 2 diabetes patients on metformin/diet therapy.
Time Frame
24h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetic patients treated with diet and metformin, 35-65 years old
Exclusion Criteria:
Type 1 diabetic patients
Treatment with insulin or sulphonylureas or glitazones
Proliferative retinopathy
Severe autonomic neuropathy
Coronary artery disease
Baseline fasting plasma glucose>200 mg/dl
Peripheral artery disease
Amputation
Heart failure
Diabetic nephropathy
Renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Schaan, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23536769
Citation
Figueira FR, Umpierre D, Casali KR, Tetelbom PS, Henn NT, Ribeiro JP, Schaan BD. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial. PLoS One. 2013;8(3):e57733. doi: 10.1371/journal.pone.0057733. Epub 2013 Mar 11.
Results Reference
derived
PubMed Identifier
23041227
Citation
Figueira FR, Umpierre D, Ribeiro JP, Tetelbom PS, Henn NT, Esteves JF, Schaan BD. Accuracy of continuous glucose monitoring system during exercise in type 2 diabetes. Diabetes Res Clin Pract. 2012 Dec;98(3):e36-9. doi: 10.1016/j.diabres.2012.09.033. Epub 2012 Oct 4.
Results Reference
derived
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Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes
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