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Exercise Training and Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01234155
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus, Type 2 Behavioral: Exercise Training - Interval Walking Behavioral: Exercise - Continuous Walking

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2010
Primary Completion Date : November 2012
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. 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.

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

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

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

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

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

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 Posted: November 4, 2010    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Thomas Solomon, Rigshospitalet, Denmark:
Insulin Sensitivity
Insulin Secretion
Beta-cell Function
Glycemic Control

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