Metabolic Syndrome Clinical Trial
— MAGNA VICTORIAOfficial title:
Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus
Verified date | May 2016 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | European Union: European Medicines Agency |
Study type | Interventional |
The most important cause of mortality amongst DM2 patients is cardiovascular disease. An early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction. Diastolic dysfunction is an independent predictor of mortality and has been shown to improve in patients on a low calorie diet. The improvement of diastolic function was associated with a reduction in triglyceride accumulation in the heart and liver. A relatively new widely prescribed therapeutic agent for DM2 patients is Liraglutide (Victoza®). Liraglutide is a Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and body weight. Next to the induction of weight loss, which is potentially beneficial for cardiac function, GLP-1 therapy might have a direct advantageous effect on the cardiovascular system. However, the effect of Liraglutide on cardiovascular function has not been investigated yet. The investigators hypothesize that treatment of DM2 patients with Liraglutide is associated with improvement of cardiovascular function and a reduction of triglyceride accumulation in end-organs.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - Informed consent - Age > 18 years and < 70 years - BMI > 25 kg/m2 - DM2 treated with metformin, metformin + SU derivative, metformin + SU derivative + insulin, or metformin + insulin for at least 3 months in the maximum tolerable dosage - HbA1c =7% and = 10.0 % - EGFR > 60 ml/min - Normal sitting blood pressure < 150/85 mm Hg and stable for at least one month Exclusion Criteria: - Use of thiazolidinediones (TZD), GLP-1 analogues, DPP-IV inhibitors, fibrates, prednisone, cytostatic or antiretroviral therapy within 6 months prior to the study - Hereditary lipoprotein disease - Psychiatric disorders and / or use of antipsychotic or antidepressant drugs at present or in the past - Hepatic disease (AST/ALT > 2 times reference values) - Endocrine disease other than diabetes mellitus type 2 - History or presence of cardiovascular disease - Any significant chronic disease (e.g. inflammatory bowel disease) - Any significant abnormal laboratory results found during the medical screening procedure - Gastrointestinal surgery (e.g. gastric bypass) - Pregnant woman or a woman who is breast-feeding - Female of child-bearing potential intending to become pregnant or is not using adequate contraceptive methods while sexually active - Allergy to intravenous contrast - Known or suspected hypersensitivity to trial products or related products - Chronic pancreatitis or previous acute pancreatitis - Personal history or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia type 2 - Claustrophobia - Metal implants or other contraindications for MRI - Recent participation in other research projects within the last 3 months or participation in 2 or more projects in one year |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Novo Nordisk A/S |
Netherlands,
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* Note: There are 43 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anthropometric measurements | Length, body weight and calculated BMI. Outcome measure: Change from baseline in kg (body weight) or kg/m2 (BMI): difference between groups |
0, 4, 8, 12, 16, 20, 26 weeks | No |
Other | Waist / hip ratio | Waist circumference divided by hip circumference. Outcome measure: change from baseline: difference between groups |
0, 4, 8, 12, 16, 20, 26 weeks | No |
Other | Systolic blood pressure | Measurements for routine clinical management Outcome measure: change from baseline in mmHg: difference between groups |
0, 4, 8, 12, 16, 20, 26 weeks | No |
Other | Diastolic blood pressure | Measurements for routine clinical management Outcome measure: change from baseline in mmHg: difference between groups |
0, 4, 8, 12, 16, 20, 26 weeks | No |
Other | Resting Energy Expenditure | Change from baseline: difference between groups Measurement with indirect calorimetry (Jaeger, OxyconPro) |
0, 4, 12, 26 weeks | No |
Other | Immunological analysis | Fluorescence-Activated Cell Sorting (FACS). Change from baseline: difference between groups. |
0, 26 weeks | No |
Other | Immunological analysis | Peripheral Blood Mononuclear Cell isolation to analyze immunological activation and status of subjects. Both quantification of white blood cells (T-cells, B-cells, macrophages) and functional analysis will be performed. Change from baseline: difference between groups |
0, 26 weeks | No |
Other | Fasting insulin level | Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | Leptin | Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | Glucagon | Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | Adiponectin | Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | CETP | Cholesteryl ester transfer protein Change from baseline: difference between groups |
0, 4, 12 and 26 weeks | No |
Other | High Sensitive C Reactive Protein | Change from baseline: difference between groups | 0, 4, 12 and 26 weeks | No |
Other | Free Fatty Acids | Change from baseline: difference between groups | 0, 4, 12 and 26 weeks | No |
Other | Cholesterol level (total, HDL and LDL) | Change from baseline: difference between groups | 0, 4, 12 and 26 weeks | No |
Other | Liver function tests (ALT, AST, AF, GGT) | Change from baseline: difference between groups | 0, 4, 12 and 26 weeks | No |
Other | Triglycerides | Change from baseline: difference between groups | 0, 4 , 12 and 26 weeks | No |
Other | QUICKI | Quantitative Insulin Sensitivity Check Index Change from baseline: difference between groups |
0 and 26 weeks | No |
Other | Albuminuria | Change from baseline of urinary albumin / creatinine ration: difference between groups | 0 and 26 weeks | No |
Other | Immunological analysis | Immunological status as assessed by RNA profiling. Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | Metabolomics | Metabolomics in urine and blood sample. Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | Insulin dose | Total daily dose (units) of insulin. Change from baseline: difference between groups | 0 and 26 weeks | No |
Other | Hypoglycaemic episodes | Number of grade 1, 2 and 3 hypoglycaemic episodes as detected with self measurement by participants. Comparison between groups. | Between week 0 and 26 | Yes |
Primary | Stroke volume | Change from baseline in ml: difference between groups | 0 and 26 weeks | No |
Primary | Ejection Fraction | Change from baseline in percentage: difference between groups | 0 and 26 weeks | No |
Primary | Cardiac output | Change from baseline in L/min: difference between groups | 0 and 26 weeks | No |
Primary | Cardiac index | Change from baseline in L/min/m2: difference between groups | 0 and 26 weeks | No |
Primary | Peak ejection rate | Change from baseline in ml end-diastolic volume/sec: difference between groups | 0 and 26 weeks | No |
Primary | Early peak filling rate | Change from baseline in ml end-diastolic volume/sec: difference between groups | 0 and 26 weeks | No |
Primary | Early deceleration peak | Change from baseline in ml/sec: difference between groups | 0 and 26 weeks | No |
Primary | Atrial peak filling rate | Change from baseline in ml/sec: difference between groups | 0 and 26 weeks | No |
Primary | Early deceleration peak / Atrial peak filling rate (E/A ratio) | Change from baseline of the ratio: difference between groups | 0 and 26 weeks | No |
Primary | Peak mitral annulus longitudinal motion | Change from baseline in cm/sec: difference between groups | 0 and 26 weeks | No |
Primary | Left ventricular filling pressure (= early peak filling rate / peak mitral annulus longitudinal motion) | Change from baseline in mmHg: difference between groups | 0 and 26 weeks | No |
Secondary | Aorta and carotid vessel wall imaging | Change from baseline of total vessel wall area in mm2: difference between groups | 0 and 26 weeks | No |
Secondary | Aorta and carotid vessel wall imaging | Change from baseline of average vessel wall thickness in mm: difference between groups | 0 and 26 weeks | No |
Secondary | Aorta and carotid vessel wall imaging | Change from baseline of a minimum vessel wall thickness in mm: difference between groups | 0 and 26 weeks | No |
Secondary | Aorta and carotid vessel wall imaging | Change from baseline of maximum vessel wall thickness in mm: difference between groups | 0 and 26 weeks | No |
Secondary | Aorta and carotid vessel wall imaging | Change from baseline of vascular distensibility (pulse wave velocity): difference between groups | 0 and 26 weeks | No |
Secondary | Adipose tissue distribution | Change from baseline of the ratio subcutaneous fat / visceral abdominal fat: difference between groups | 0 and 26 weeks | No |
Secondary | Total body fat | Change from baseline of total fat volume in ml: difference between groups | 0 and 26 weeks | No |
Secondary | Epicardial fat volume | Change from baseline in cm3: difference between groups | 0 and 26 weeks | No |
Secondary | Magnetic Resonance Spectroscopy of the heart | Change from baseline in percentage: difference between groups | 0 and 26 weeks | No |
Secondary | Magnetic Resonance Spectroscopy of the liver | Change from baseline in percentage: difference between groups | 0 and 26 weeks | No |
Secondary | Magnetic Resonance Spectroscopy of the kidney | Change from baseline in percentage: difference between groups | 0 and 26 weeks | No |
Secondary | HBA1C | Measurements will be used to guide therapeutic management The outcome measure glycemic control will be based on the average HBA1C level of all measurements and regards: difference between groups. |
0,8, 12, 16 and 26 weeks | No |
Secondary | Fasting blood glucose level | Fasting blood glucose levels will be used to guide therapeutic management and for safety reasons. Outcome measure: the difference between groups of the average of all measurements. |
0, 4, 8, 12, 16, 20, 26 weeks | Yes |
Secondary | Myocardial T1 - mapping | Change from baseline of myocardial T1 - values before and after contrast: difference between groups | 0 and 26 weeks | No |
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