Status:

UNKNOWN

Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study

Lead Sponsor:

Post Graduate Institute of Medical Education and Research, Chandigarh

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

MALE

25-50 years

Brief Summary

To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Detailed Description

Several clinical studies demonstrated that pioglitazone not only improves insulin sensitivity but also decreases plasma androgen concentrations (DHEAS and androstenedione) in women with polycystic ova...

Eligibility Criteria

Inclusion

  • HbA1c level of 7.5% or less on stable dosages of sulphonylurea (glimepiride 1-6mg/day) and metformin (1-2g/day) for at least six weeks and BMI of 20-30 kg/m2.

Exclusion

  • hepatic impairment, coronary artery disease and or heart failure, renal failure, those who requires insulin therapy or HbA1c \>7.5%, presence of macular edema and serum albumin \<3gm/dL.

Key Trial Info

Start Date :

September 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2012

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT01206400

Start Date

September 1 2010

End Date

January 1 2012

Last Update

June 30 2011

Active Locations (1)

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PGIMER

Chandigarh, Chandigarh, India, 160012