The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial. Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.

Official Title
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Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Training and liraglutide
* Other: Training and placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed oral and written consent Diagnosed with type 2 diabetes according to the criteria of the WHO HbA1C: 7-11% (doing treatment with diet and/or metformin) Age >18 years BMI >25 kg/m2 <40 kg/m2 Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies Exclusion Criteria: Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures. Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones Ongoing abuse of alcohol or narcotics Impaired hepatic function (liver transaminases >2 times upper normal limit) Impaired renal function (se-creatinine >150μM and/or albuminuria) Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg) Anaemia Any condition that the investigators feels would interfere with trial participation Receiving any investigational drug within the last 3 months

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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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training and liraglutide<br>Treatment with both training and liraglutide for 16 weeks | Other: Training and liraglutide<br> <br> |
| Placebo Comparator: Training and placebo<br>Treatment wiht both training and placebo for 16 weeks | Other: Training and placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c from baseline to 16 weeks. Glycated haemoglobin (HbA1c) is a form of haemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time (12 weeks). | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake (VO2peak) | Changes in VO2peak from baseline to 16 weeks | 16 weeks | 
| Body weight | Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan | 16 weeks | 
| Blood pressure | Changes in blood pressure from baseline to 16 weeks | 16 weeks | 
| Glycaemic control | Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response | 16 weeks | 
| Meal test | The changes in the postprandial response of incretin hormones, insulin and glucose, glucagon and the microvascular blood flow will be evaluated. Changes in blood leves of triglycerides and cholesterol. | 16 weeks | 
| Myocardial echocardiography |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, Training, Exercise, Type 2 Diabetes