CompletedPhase 4

Galantamine Effects in Patients With Metabolic Syndrome

Brazil60 participantsStarted 2014-03

Plain-language 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.

Who can participate

Age range18 Years – 59 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Composite measure of cytokines and adipokines levels, to include IL-1, IL-6, TNF alpha, leptin and adiponectin

Timeframe: 12 weeks

Trial details

NCT IDNCT02283242

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03