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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Training and liraglutide; Other: Training and placebo

• Registration Number: NCT01455441
• Lead Sponsor: Tina Vilsboll

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Primary Completion: 2013-06
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training and liraglutide	Training and liraglutide	Treatment with both training and liraglutide for 16 weeks
Training and placebo	Training and placebo	Treatment wiht both training and placebo for 16 weeks

Primary Outcome Measures

Name	Time	Method
HbA1c	16 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Blood pressure	16 weeks	Changes in blood pressure from baseline to 16 weeks
Glycaemic control	16 weeks	Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response
Myocardial echocardiography	16 weeks
Maximal oxygen uptake (VO2peak)	16 weeks	Changes in VO2peak from baseline to 16 weeks
Body weight	16 weeks	Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
Meal test	16 weeks	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.

Trial Locations

Locations (1)

Department of Internal Medicine, Gentofte Hospital; 🇩🇰 Hellerup, Denmark