Testosterone Replacement in Metabolic Syndrome and Inflammation

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• patients with Metabolic Syndrome according to ATPIII

• patients with mild hypogonadism (both testosterone evaluations between 6 and 11 nmol/L)

• patients naïve to hypoglycemic therapies

Exclusion Criteria:

• patients on hypoglycemic medications

• patients with severe hypogonadism (<5 nmol/L)

• patients with borderline T values hypogonadism (>11 nmol/L)

• patients with contraindication to testosterone therapy: prostate cancer, PSA>4 ng/ml, severe hepatic or renal insufficiency, Hb>17, Htc>52%, severe urinary retention