The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
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.
Type 2 Diabetes
Other: Training and liraglutide
Other: Training and placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?|
- HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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).
- Maximal oxygen uptake (VO2peak) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in VO2peak from baseline to 16 weeks
- Body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
- Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in blood pressure from baseline to 16 weeks
- Glycaemic control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response
- Meal test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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.
- Myocardial echocardiography [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Training and liraglutide
Treatment with both training and liraglutide for 16 weeks
|Other: Training and liraglutide|
Placebo Comparator: Training and placebo
Treatment wiht both training and placebo for 16 weeks
|Other: Training and placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455441
|Department of Internal Medicine, Gentofte Hospital|
|Hellerup, Denmark, 2900|