Exercise Training and Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234155
• Other study ID #: H-1-2010-027
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: December 2, 2014
• Start date: August 2010
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Rigshospitalet
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.	0 and 4 months	No
Secondary	Beta-cell Function	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.	0 and 4 months	No
Secondary	Body Composition	DXA and MRI will be used to assess changes in whole body and regional adiposity.	0 and 4 months	No