Obesity related hypogonadism: clomiphene citrate treatment effects

• Grant number: 13/16781-1
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2014
• End date: July 31, 2017
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Elaine Maria Frade Costa
• Grantee: Elaine Maria Frade Costa
• Host Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Andressa Heimbecher Soares ; Cintia Cercato

Abstract

The increasing obesity incidence worldwide and the fact that obesity can lead to secondary hypogonadism in young man, brings the need to evaluate new treatments to hypoandrogenism. The standard testosterone replacement therapy (TRT) ameliorates the metabolic parameters but can cause infertility, and its benefits regarding cardiovascular parameters such endothelial dysfunction are still controversial. The primary objective of this research is to evaluate the flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, E-selectin, sVCAM-1 and progenitor endothelial cells in young man with obesity related hypogonadism submitted to a 12 week treatment with Clomiphene Citrate. The secondary objectives are the evaluation of metabolic parameters (weight, abdominal circumference, glycaemia, total cholesterol, fractions and triglycerides, HOMA index and bioimpedanciometry parameters) and hormonal parameters (total testosterone levels, SHBG, LH, FSH and Estradiol). Methods/Design: A sample of 70 male patients aged 20 to 50 years-old will be randomized in two groups (placebo and intervention) and will be followed for 12 weeks. The laboratory scan described and the FMDAB will be performed at the randomization and at the end of the 12-week trial. It is expected to collect data regarding the behavior of the endothelial function, metabolic and hormonal parameters in both groups. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

SOARES, ANDRESSA HEIMBECHER; HORIE, NIDIA CELESTE; PICCININ CHIANG, LUCAS AUGUSTO; CARAMELLI, BRUNO; MATHEUS, MARIANA GOMES; CAMPOS, ALEXANDRE HOLTHAUSEN; MARTI, LUCIANA CAVALHEIRO; ROCHA, FERNANDA AGOSTINI; MANCINI, MARCIO C.; FRADE COSTA, ELAINE MARIA; et al. Effects of clomiphene citrate on male obesity-associated hypogonadism: a randomized, double-blind, placebo-controlled study. International Journal of Obesity, v. 42, n. 5, p. 953-963, JUN 2018. (13/16781-1)