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

P

Postgraduate Institute of Medical Education and Research

Status

Unknown

Conditions

Type 2 Diabetes Mellitus

Study type

Observational

Funder types

Other

Identifiers

NCT01206400
pioglitazonetestosterone

Details and patient eligibility

About

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

Full 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 ovary syndrome (PCOS) . However the reduction in the androgen levels in PCOS is whether secondary to increase in the insulin sensitivity or due to direct effect of thiazolidinediones on steroidogenesis is not known.So far, two human studies have been conducted regarding the effects of rosiglitazone (a thiazolidinedione group of drug) on testosterone level, one in healthy individuals and another was in patients of type 2 diabetes with hypogonadism . But these studies gave equivocal results as the study population were different. Hence we plan to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Enrollment

45 estimated patients

Sex

Male

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.

Trial design

45 participants in 1 patient group

pioglitazone vs placebo
Description:
15 patients in pioglitazone group and 15 in placebo group

Trial contacts and locations

0

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Central trial contact

Dr anil Bhansoli, MD.DM; sridhar subbiah, MD medicine

Data sourced from clinicaltrials.gov

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