First two authors have equal contribution.
Effect of pioglitazone on testosterone in eugonadal men with type 2 diabetes mellitus: a randomized double-blind placebo-controlled study
Article first published online: 25 JAN 2013
© 2012 Blackwell Publishing Ltd
Volume 78, Issue 3, pages 454–459, March 2013
How to Cite
Sridhar, S., Walia, R., Sachdeva, N. and Bhansali, A. (2013), Effect of pioglitazone on testosterone in eugonadal men with type 2 diabetes mellitus: a randomized double-blind placebo-controlled study. Clinical Endocrinology, 78: 454–459. doi: 10.1111/j.1365-2265.2012.04510.x
- Issue published online: 25 JAN 2013
- Article first published online: 25 JAN 2013
- Accepted manuscript online: 20 JUL 2012 11:40AM EST
- Manuscript Revised: 17 JUL 2012
- Manuscript Accepted: 17 JUL 2012
- Manuscript Revised: 19 JUN 2012
- Manuscript Received: 25 MAY 2012
Pioglitazone is an insulin sensitizer used for the management of type 2 diabetes mellitus (T2DM). It has been shown to reduce testosterone level in patients with polycystic ovarian syndrome. However, its effect on testosterone in men has not been studied.
Research design and methods
A randomized, double-blind, placebo-controlled trial with 6 months follow-up. Fifty (25 in each group) eugonadal men (well virilized and total testosterone ≥12 nm) with T2DM, aged 30–55 year and HbA1c of ≤7·5% were randomly assigned to receive pioglitazone 30 mg per day or placebo along with existing glimepiride and metformin therapy.
As compared to placebo, 6 months of pioglitazone therapy in patients with T2DM resulted in significant reduction in mean total testosterone level (16·1 to 14·9 vs 17·1 to 17·0 nm; P = 0·031), calculated free testosterone (P = 0·001) and bioavailable testosterone (P = 0·000) despite significant increase in sex hormone-binding globulin (P = 0·000). Plasma androstenedione (∆4) level increased (1·5 to 1·9 vs 1·7 to 1·7 ng/ml; P = 0·051) following pioglitazone therapy. The decrease in testosterone was independent of change in body weight, body fat and HbA1c.
Pioglitazone therapy significantly decreases total, free and bioavailable testosterone in eugonadal men with T2DM. The effects of these alterations need to be determined by further long-term studies.