Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887094
• Other study ID #: 08-180
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: August 3, 2011
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: August 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise
• Treatment

Intervention

Behavioral:
• Acute aerobic exercise
Aerobic exercise (on a cycle ergometer, for 50 min)
• Acute aerobic-resistance exercise
Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24h	No