CompletedPhase 4

Testosterone Replacement in Metabolic Syndrome and Inflammation

Italy82 participantsStarted 2004-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fat-Free Mass (kg)

Timeframe: 3 months

Trial details

NCT IDNCT01123278

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

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