Galantamine Effects in Patients With Metabolic Syndrome

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

It is recognized that inflammation can be modulated by cholinergic stimulation and that galantamine, an inhibitor of acetylcholinesterase enzyme with central nervous system action, has showed an anti-inflammatory effect, reducing body weight, abdominal fat and improvement in tissue insulin resistance in animal models. Galantamine is a safe drug that is used to treat alzheimer disease.Galantamine treatments of patients with the metabolic syndrome may represent a significant advance in management of this disease. This study aims to investigate the effects of galantamine on inflammatory markers, as well as on abdominal visceral and epicardial fat and oxidative stress in patients with metabolic syndrome. This is a pioneering study that will include expert support. The enrolling of subjects will have continuous monitoring throughout the period of treatment. The study is a double blind randomized prospective study with 60 patients with metabolic syndrome, to be randomized at ratio of 1: 1 placebo and galantamine. The dose of galanthamine is the standard clinically approved (8 and 16 mg). The tracking method include metabolic analysis, inflammatory and oxidative stress markers, hemodynamic evaluation with hear rate variability (sympatho vagal modulation) before, during and after treatment. Computerized tomography assessment of visceral abdominal and epicardial fat before and after treatment will be performed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Feinstein Institute for Medical Research; University of Nove de Julho
• Treatments: Cholinergic Agents; Galantamine

Criteria

Inclusion:

• Diagnosis of Metabolic Syndrome based on recently established criteria (three abnormal findings of the following five)

• Increased abdominal circumference ≥ 102 cm for men and 90 cm for women

• Low plasma level of HDL cholesterol < 40md/dL for men and 50 mg/dL for women

• Increased values for plasma triglycerides > 150 mg/dL

• Elevated blood pressure ≥130/85 mmHg

• Elevated level of blood sugar value to 100 mg/dL

• Body Mass Index (BMI) between 25 and 39, with weight maintenance diet and stable for at least 6 months before study entry

• Normal renal function and thyroid function

• Able to participate in the study by signing an informed consent form and comply with study stages throughout its duration

Exclusion:

• On use of antidiabetic medication

• Triglyceride levels ≥ 400 mg/dL or use of lipid lowering medication

• Levels of aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 200 U/L

• Levels of aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 200 U/L

• The office systemic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg at rest

• BMI ≥ 40kg/m²

• In use of antihypertensive drugs that interfere with the heart rate variability

• On the use of drugs that have known or probable interaction with galantamine:

amitriptyline, fluoxetine, fluvoxamine, ketoconazole, oxybutynin, paroxetine, quinidine

• Already participant in regular exercise programs, defined as 90 minutes of activity per week

• Medical history, previous diagnosis or previous supplementary examinations indicating presence of cardiac arrhythmias, coronary artery disease, valvular disease, heart failure, chronic obstructive pulmonary disease, acute or chronic liver disease, renal insufficiency, thyroid disorders, chronic inflammatory diseases, cancer, positive status for HIV, other debilitating diseases

• Abuse of alcohol or other substances in the 12 months prior to study entry

• History of major depression or patients with suicidal ideation

• Personal history of eating disorder

• Utilization of drugs for obesity

• Use of serotonin reuptake inhibitors

• Pregnancy or desire to become pregnant during the study period