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Clinical Trials/NCT01234155
NCT01234155CompletedNot Applicable

Exercise Training and Type 2 Diabetes

Rigshospitalet, Denmark2 sites in 1 country32 target enrollmentStarted: August 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Glycemic Control

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Glycemic Control

Time Frame: 0 and 4 months

Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.

Secondary Outcomes

  • Beta-cell Function(0 and 4 months)
  • Body Composition(0 and 4 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Solomon

Group Leader

Rigshospitalet, Denmark

Study Sites (2)

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