Status:
COMPLETED
Galantamine Effects in Patients With Metabolic Syndrome
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
University of Nove de Julho
Feinstein Institute for Medical Research
Conditions:
Abdominal Obesity Metabolic Syndrome
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief 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-...
Detailed Description
Population: patients with metabolic syndrome; Intervention: Galantamine; Comparation: Placebo; Outcomes (primary): proinflammatory cytokines levels. Description: Patients with criteria of Metabolic ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02283242
Start Date
March 1 2014
End Date
February 1 2017
Last Update
February 15 2017
Active Locations (1)
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1
University of São Paulo, Heart Institute, Medical School
São Paulo, São Paulo, Brazil, 05403-900