Exercise Training and Type 2 Diabetes

Study Overview
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Brief Summary
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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).

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Exercise Training - Interval Walking
* Behavioral: Exercise - Continuous Walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Exercise - Continuous Walking<br> | Behavioral: Exercise - Continuous Walking<br>* 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.<br>|
| Experimental: Exercise - Interval Walking<br> | Behavioral: Exercise Training - Interval Walking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | Fasting glucose, two-hour glucose during OGTT, and hemoglobin A1c will be measured. | 0 and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body Composition | DXA and MRI will be used to assess changes in whole body and regional adiposity. | 0 and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Diabetes, Obesity, Insulin Sensitivity, Insulin Secretion, Beta-cell Function, Glycemic Control, GIP, GLP-1