Galantamine Effects in Patients With Metabolic Syndrome (NCT02283242) | Clinical Trial Compass
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 range
18 Years – 59 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite measure of cytokines and adipokines levels, to include IL-1, IL-6, TNF alpha, leptin and adiponectin