Exercise Training and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Exercise Training - Interval Walking; Behavioral: Exercise - Continuous Walking

• Registration Number: NCT01234155
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2012-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise - Interval Walking	Exercise Training - Interval Walking	-
Exercise - Continuous Walking	Exercise - Continuous Walking	-

Primary Outcome Measures

Name	Time	Method
Glycemic Control	0 and 4 months	Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured.

Secondary Outcome Measures

Name	Time	Method
Beta-cell Function	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.
Body Composition	0 and 4 months	DXA and MRI will be used to assess changes in whole body and regional adiposity.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark