Galantamine Effects in Patients With Metabolic Syndrome (GALANTA-MS)
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|ClinicalTrials.gov Identifier: NCT02283242|
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Obesity Metabolic Syndrome||Drug: Galantamine Drug: Placebo (for galantamine)||Phase 4|
Population: patients with metabolic syndrome; Intervention: Galantamine; Comparation: Placebo; Outcomes (primary): proinflammatory cytokines levels.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Cholinergic Stimulation on Visceral Fat, Oxidative Stress and Inflammatory Markers in Patients With Metabolic Syndrome: a Randomized Clinical Trial|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||February 2017|
Oral use for 12 weeks
Other Name: Reminyl ER
Placebo Comparator: Placebo
Drug: Placebo (for galantamine)
Oral use for 12 weeks
Other Name: Placebo
- Composite measure of cytokines and adipokines levels, to include IL-1, IL-6, TNF alpha, leptin and adiponectin [ Time Frame: 12 weeks ]
- Glucose, triglycerides and high density lipoprotein cholesterol levels [ Time Frame: 12 weeks ]
- Insulin levels [ Time Frame: 12 weeks ]
- Arterial blood pressure levels [ Time Frame: 12 weeks ]
- Heart Rate Variability [ Time Frame: 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 ]
- Abdominal fat levels [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283242
|University of São Paulo, Heart Institute, Medical School|
|São Paulo, Brazil, 05403-900|
|Principal Investigator:||Fernanda M Consolim Colombo, Dra||University of Sao Paulo|