Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes (CGMSexercise)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 22, 2009 | ||||
| Last Updated Date | August 3, 2011 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00887094 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes | ||||
| Official Title ICMJE | Acute and Subacute Effects of Aerobic Training vs Aerobic/Resistance Training Upon Glucose Profile Evaluated Through Continuous Glucose Monitoring System in Type 2 Diabetes | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 14 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 35 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00887094 | ||||
| Other Study ID Numbers ICMJE | 08-180 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Beatriz Schaan, Hospital de Clinicas de Porto Alegre | ||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||
| Verification Date | August 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||