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Exercise Training and Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01234155
First received: November 1, 2010
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Glycemic Control [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    DXA and MRI will be used to assess changes in whole body and regional adiposity.


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: December 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: November 1, 2010
Last Updated: March 14, 2013
Health Authority: Denmark: Rigshospitalet

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013