- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02283242
Galantamine Effects in Patients With Metabolic Syndrome (GALANTA-MS)
Effects of Cholinergic Stimulation on Visceral Fat, Oxidative Stress and Inflammatory Markers in Patients With Metabolic Syndrome: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Population: patients with metabolic syndrome; Intervention: Galantamine; Comparation: Placebo; Outcomes (primary): proinflammatory cytokines levels.
Description:
Patients with criteria of Metabolic Syndrome (with the 2005 revised NCEP ATP III criteria) will be randomized to 2 groups: use of galantamina (30 patients) or placebo (30 patients) in the following sequency:
I) 4 weeks of treatment with 8 mg of galantamine or placedo (oral ingestion capsules);
II) 8 weeks of treatment with 16 mg of galantamine or placebo (oral ingestion capsules).
Participants will receive a diary to record any symptoms that may present and will be instructed to bring it at each study visit.
Before randomization all participants will go through the following procedures:
- Clinical and neurological evaluation;
- Blood sample analysis of cytokines, oxidative stress and biochemical parameters;
- Multidetector computed tomographic (MDCT) scan of abdomen (visceral - abdominal and epicardial fat) and thorax (calcium score);
- blood pressure recording for hemodynamic evaluation and assessment of heart rate variability
- 24h ambulatory blood pressure measurement
These procedures will be repeated at the end of the protocol.
This is a randomized controlled trial study. Blinding status: Patients, investigators, and outcome assessors.
All participants were outpatients.
The invitation to participate in the study and all the details of the protocol will be explained.
Once the patients have the criteria for inclusion, they receive the cards with capsules containing placebo or galantamine according to continuous numerical order provided by the pharmacy that prepared and randomized such substances (numbered containers).
Drug and placebo will be manipulated and encapsulated in identical packaging at the Central Pharmacy of School of Medicine, University of São Paulo.
We will use simple randomisation using a randomisation table created by computer software - graphpad Software- quickcalcs.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil, 05403-900
- University of São Paulo, Heart Institute, Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Galantamine
|
Oral use for 12 weeks
Other Names:
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Placebo Comparator: Placebo
|
Oral use for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite measure of cytokines and adipokines levels, to include IL-1, IL-6, TNF alpha, leptin and adiponectin
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose, triglycerides and high density lipoprotein cholesterol levels
Time Frame: 12 weeks
|
12 weeks
|
Insulin levels
Time Frame: 12 weeks
|
12 weeks
|
Arterial blood pressure levels
Time Frame: 12 weeks
|
12 weeks
|
Heart Rate Variability
Time Frame: 12 weeks
|
12 weeks
|
Composite measure of markers of oxidative stress, to include: total amount of free radicals, malondialdehyde, allantoin, anpha-1-antiproteinase, oxidize/reduced glutatione ratio
Time Frame: 12 weeks
|
12 weeks
|
Abdominal fat levels
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fernanda M Consolim Colombo, Dra, University of Sao Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Disease
- Overnutrition
- Nutrition Disorders
- Insulin Resistance
- Hyperinsulinism
- Obesity
- Syndrome
- Metabolic Syndrome
- Obesity, Abdominal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Parasympathomimetics
- Galantamine
Other Study ID Numbers
- CAAE:27386114.9.0000.0068
- 2013/22250-9 (Other Grant/Funding Number: Fundação de Amparo à Pesquisa do Estado de São Paulo)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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