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Exercise Training and Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234155
First Posted: November 4, 2010
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
  Purpose
The purpose of this study is to assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. The effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. Changes in glycemic control will be examined using oral glucose tolerance tests (OGTT) with stable isotope methodology. In addition, insulin sensitivity and secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Condition Intervention
Diabetes Mellitus, Type 2 Behavioral: Exercise Training - Interval Walking Behavioral: Exercise - Continuous Walking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Thomas Solomon, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Glycemic Control [ Time Frame: 0 and 4 months ]
    Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.


Secondary Outcome Measures:
  • Beta-cell Function [ Time Frame: 0 and 4 months ]
    Glucose tolerance tests and hyperglycemic clamps combined with GLP-1 / GIP will be conducted. Glucose tracer kinetics and C-peptide deconvolution will be used to assess pancreatic function.

  • Body Composition [ Time Frame: 0 and 4 months ]
    DXA and MRI will be used to assess changes in whole body and regional adiposity.


Enrollment: 32
Study Start Date: August 2010
Study Completion Date: November 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Exercise - Continuous Walking Behavioral: Exercise - Continuous Walking
Duration: 4 months. Exercise training sessions will be performed 3-5 days/week and will consist of walking for up to 60 minutes/day at 55% VO2max.
Experimental: Exercise - Interval Walking Behavioral: Exercise Training - Interval Walking
Duration: 4 months. Exercise training sessions will be performed 3-5 days/week. Sessions will consist of walking for 3 minutes at 70% VO2max followed by 3 minutes at 40% VO2max for up to 60 minutes/day.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 to 80
  • normal glucose tolerance, impaired glucose tolerance, or type 2 diabetes (as evidenced by use of oral hypoglycemic medication or 2-hour OGTT glucose > 11.1 mmol/l)

Exclusion Criteria:

  • Insulin treatment or type 1 diabetes
  • BMI <19 or >40
  • Physically active
  • Undergoing weight-loss/gain
  • Pregnancy
  • Contraindication to exercise (ECG/CPX)
  • Significant cardiovascular disease
  • History of renal/hepatic/gastrointestinal/pulmonary disease
  • Clotting or bleeding disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234155


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Thomas P Solomon, Ph.D. Rigshospitalet, Denmark
Principal Investigator: Kristian Karstoft, M.D. Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Solomon, Group Leader, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01234155     History of Changes
Other Study ID Numbers: H-1-2010-027
First Submitted: November 1, 2010
First Posted: November 4, 2010
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Thomas Solomon, Rigshospitalet, Denmark:
Exercise
Diabetes
Obesity
Insulin Sensitivity
Insulin Secretion
Beta-cell Function
Glycemic Control
GIP
GLP-1

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


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