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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training and liraglutide | Active Comparator | Treatment with both training and liraglutide for 16 weeks |
|
| Training and placebo | Placebo Comparator | Treatment wiht both training and placebo for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training and liraglutide | Other |
| ||
| Training and placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Gentofte Hospital | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Other |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |