Galantamine Effects in Patients With Metabolic Syndrome
Condition: Abdominal Obesity Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Obesity, Abdominal; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Galantamine; Placebo (for galantamine)
Intervention type(s): Drug; Drug
Intervention description(s): Oral use for 12 weeks; Oral use for 12 weeks
Other intervention name(s): Reminyl ER; Placebo
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cholinergic Antagonists; Inflammation; Oxidative Stress