Effect of liraglutide (antidiabetic drug) on physical performance in patiens with type 2 diabetes.
- Conditions
- Patients with Diabetes type 2.Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-005197-63-ES
- Lead Sponsor
- Ana M. Wägner
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-Type 2 diabetes treated with oral agents (including metformin if tolerated and not contraindicated), a maximum of 2 intermediate-long acting insulin injections per day or a combination of both.
-HbA1c between 7 and 10 %.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Severe renal failure (estimated CFR<30ml/min)
Liver failure (child-pugh score > 6 points)
Present or planned pregnancy/breastfeeding or inadequate contraception
intolerance/allergy to liraglutide
Familiar/personal history of medullary thyroid cancer or multiple endocrine neoplasia 2
personal history of pancreatitis
triglyceride concentrations above 500mg/dl or alcohol intake>40 grams/day
known active malignancy
tratment with GLP1 agonist or DPP4 inhibitors in the previous 3 months
factors potentially interfering with adherence to treatment or follow-up (investigator´s criteria)
known coronary artery disease with exercise-induced ischaemia
planned revascularisations in the following 6 months
severe symptoms of heart failure (NYHA class IV)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this trial is to assess the effect pf a GLP1 agonist on clinically relevant measures of myocardial function.;Secondary Objective: Distance covered during a 6 minute walk test.<br>Left ventricular function parameters (ecocardiography).<br>Diastolic function (ecocardiography)<br>Total number of steps in 24 hours, registered by Holter.<br>Quality of life questionnaires.<br>HbA1c amd total daily insulin dose.<br>Lipids nd apoB<br>CRP<br>ProBNP<br>Fasting C peptide<br>Daily medication<br>Body weight, waist circumference and BMI;Primary end point(s): Fitness, assessed as maximum oxygen comsumption (VO2 max) on a cycle ergometer test.;Timepoint(s) of evaluation of this end point: Baseline and 26 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Distance covered during a 6 minute walk test.<br>left ventricular function parameters.<br>Diastolic function.<br>Total number of steps in 24 hours, registered by Holter.<br>Quality of life questionnaires.<br>HbA1c amd total daily insulin dose.<br>Lipids nd apoB<br>CRP<br>ProBNP<br>Fasting C peptide<br>Daily medication<br>Body weight, waist circumference and BMI;Timepoint(s) of evaluation of this end point: Baseline and 26 weeks and 12 weeks for some measurementes