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About
The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.
Full description
Aim: To test if treatment with liraglutide a GLP-1 analogue in 18 weeks improves diastolic performance in type 2 diabetes (DM2) patients with diastolic dysfunction, compared to placebo. Furthermore, analyzing cardiac MRI indices of fibrosis and the effect on myocardial perfusion.
The investigators find that especially diastolic dysfunction is of interest, because it is highly overrepresented in DM2 patients and no treatment exists. Glucagon-like peptide 1 analogue could be a possible treatment agent, by increasing the energy level in the myocardium. No previous study has tested the effect of treatment with a glucagon-like peptide 1 analogue on diastolic dysfunction.
Design: A randomised double-blinded placebo-controlled clinical trial. Sample size: 40 patients, 20 in each group. The superior inter-study reproducibility results in considerably lower calculated sample sizes (reductions of 55% to 93%) required by cardiac MR compared with echocardiography to show clinically relevant changes. Power calculations show that only 30 patients are needed form our primary outcome, to allow for dropouts the investigators have chosen to include 40 patients.
Intervention: After randomization, patients will be treated with placebo or liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. A cardiac MRI scan and an echocardiography will be preformed at baseline and after 18 weeks.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Lack of consent.
NYHA class IV
Type 1 diabetes mellitus
Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomisation (visit 1)
Glitazon therapy within 30 days prior to randomisation (visit 1)
Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg*
Supine systolic blood pressure <85 mmHg measured at visit 0
Significant valvular heart disease
Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
Myocardial infarction, unstable angina, angina on exertion (≥CCS class 2) or coronary revascularization within 3 months prior to randomisation (visit 1)
Hospitalisation due to incompensated heart disease within 30 days to randomisation (visit 1)
HbA1c >10% at visit 0
eGFR< 60 ml/min/1,73 m2 at visit 0
Liver disease with aspartate aminotransferase/alanine aminotransferase >3 times upper limit of normal measured at visit 0**
Hypokalaemia (P-potassium <3.5 mmol/L) or hyperkalaemia (P-potassium >5.5 mmol/L) measured at visit 0**
Anaemia (haemoglobin <6.5 mmol/L) measured at visit 0**
Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
Prolonged use (> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to visit 0
Women of childbearing potential who are not on acceptable contraception. See below.
Pregnant or breastfeeding women
Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for ≥ 5 years
Alcohol/drug abuse
Chronic or previous acute pancreatitis
History of thyroid adenoma or carcinoma
Inflammatory bowel disease
Clinical signs of diabetic gastroparesis
ICD/pacemaker or other contraindications to MRI scan
Severe claustrophobia
Atrial fibrillation
Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
Known or suspected hypersensitivity to trial product or related products
Current participation in any other clinical intervention trial
Receipt of an investigational drug with 30 days prior to visit 0
Other concominant disease or treatment that according to investigator's assessment makes the patient unsuitable for participation in the study
Measured twice at visit 0. In case of elevation, an ambulatory (24-hour) blood pressure will be performed, and the result of this will be conclusive
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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