ECE2016 Oral Communications Reproduction & Endocrine Disruption (5 abstracts)
Effect of clomiphene citrate and metformin on testosterone levels in hypogonadal obese men with impaired glucose tolerance (IGT) or type 2 diabetes (DM2)
Carla Pelusi 1, , Vito Giagulli 3, , Margherita Baccini 1 , Flaminia Fanelli 1, , Marco Mezzullo 1, , Alessia Fazzini 1, , Elena Casadio 1 , Olga Prontera 1 , Uberto Pagotto 1, & Renato Pasquali 1
1University of Bologna, Division of Endocrinology, Department of Medical and Surgical Sciences, Bologna, Italy; 2University of Bologna, Center for Applied Biomedical Research, Bologna, Italy; 3University of Bari, Endocrinology and Metabolic Diseases, Bari, Italy; 4Conversano Hospital, Outpatient Clinic for Endocrinology and Metabolic Diseases, Conversano, Italy.
Low testosterone (T) levels are often found in obese men with metabolic abnormalities, however the mechanism underling this condition is unclear. This study aimed to evaluate the effectiveness of clomiphene citrate (CC) in increasing T levels and improving metabolic control in hypogonadal obese men with IGT or DM2. A randomized cross-over double blind controlled study was conducted in twenty obese hypogonadal caucasian men, mean age 47 ys, classified in IGT (n=11) or DM2 (n=9). Participants were assigned to receive either 25 mg/day of CC plus 2 g/day of metformin (MET) or placebo plus 2 g/day of MET for 3 months. After 6 weeks wash-out period, subjects were moved to the alternate arm for additional 3 months. Inclusion criteria were age (35–56 ys), BMI> 30 kg/m2, T level < 3 ng/ml and glycemia compatible with IGT or DM2. At baseline and at the end of each phase, BMI, glycemia, T and E2 were evaluated. T and E2 were measured by LC/MS-MS. In the CC+MET treatment phase, T and E2 levels increased significantly compared to baseline (T=2.91±0.76 ng/ml vs 5.86±1.69 ng/ml, P<0.001; E2=24±8 pg/ml vs 49±21 pg/ml, P<0.001) whereas glycemia and BMI decreased (glycemia=105 ± 24 mg/dl vs 99±26 mg/dl, P<0.019; BMI=36.0±5.9 kg/m2 vs 35.4± 5.7 kg/m2; P<0.007). Indeed, in the placebo + MET phase no significant changes in any of these parameters were observed. The sex-hormonal changes were similar in IGT and DM2 subjects. Only CC + MET therapy was able to significantly increase serum T levels in all participants independently of the metabolic state and to reduce BMI and glycemia.
Volume 41
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