Galantamine Effects in Patients With Metabolic Syndrome
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Sao Paulo
Collaborators:
Feinstein Institute for Medical Research University of Nove de Julho