Diabetes Mellitus, Type 2
Conditions
Keywords
Exercise, Diabetes, Obesity, Insulin Sensitivity, Insulin Secretion, Beta-cell Function, Glycemic Control, GIP, GLP-1
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).
Interventions
BEHAVIORALExercise 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.
BEHAVIORALExercise - 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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | 0 and 4 months | Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed