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

November 1, 2010
March 14, 2013
August 2010
November 2012   (final data collection date for primary outcome measure)
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.
Glycemic Control [ Time Frame: After 4 months ] [ Designated as safety issue: No ]
Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.
Complete list of historical versions of study NCT01234155 on ClinicalTrials.gov Archive Site
  • 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.
  • Beta-cell Function [ Time Frame: After 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: After 4 months ] [ Designated as safety issue: No ]
    DXA and MRI will be used to assess changes in whole body and regional adiposity.
Not Provided
Not Provided
 
Exercise Training and Type 2 Diabetes
Not Provided

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
  • 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.
  • No Intervention: Control
  • Experimental: Exercise - Continuous Walking
    Intervention: Behavioral: Exercise - Continuous Walking
  • Experimental: Exercise - Interval Walking
    Intervention: Behavioral: Exercise Training - Interval Walking

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01234155
H-1-2010-027
No
Thomas Solomon, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Thomas P Solomon, Ph.D. Rigshospitalet, Denmark
Principal Investigator: Kristian Karstoft, M.D. Rigshospitalet, Denmark
Rigshospitalet, Denmark
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP