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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00887094
First received: April 22, 2009
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Treatment
Exercise
 Behavioral: Acute aerobic exercise
Behavioral: Acute aerobic-resistance exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

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. [ Time Frame: 24h ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic exercise
One bout of aerobic physical training will be performed on a cycle ergometer for 50 min
 Behavioral: Acute aerobic exercise
Aerobic exercise (on a cycle ergometer, for 50 min)
Other Name: There are no other names
Experimental: Aerobic-resistance exercise
One bout of aerobic-resistance physical training will be performed on a cycle ergometer added by a strenght training for 50 min (total)
 Behavioral: Acute aerobic-resistance exercise
Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)
Other Name: There are no other names

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887094

Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Beatriz Schaan, PhD Hospital de Clinicas de Porto Alegre
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Beatriz Schaan, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00887094     History of Changes
Other Study ID Numbers: 08-180
Study First Received: April 22, 2009
Last Updated: August 3, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Diabetes mellitus
Exercise
Endurance
Resistance
Continuous glucose monitoring system

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013