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NCT01206400 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01206400
Other study ID # pioglitazonetestosterone
Secondary ID
Status Recruiting
Phase N/A
First received September 20, 2010
Last updated June 28, 2011
Start date September 2010
Est. completion date January 2012

Study information
Verified date September 2010
Source Postgraduate Institute of Medical Education and Research
Contact sridhar subbiah, MD medicine
Phone 9914411026
Email drsridharjipmer@gmail.com
Is FDA regulated No
Health authority India:Ministry of health and family welfare
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 50 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
India PGIMER Chandigarh

Sponsors (1)
Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (1)

Kapoor D, Channer KS, Jones TH. Rosiglitazone increases bioactive testosterone and reduces waist circumference in hypogonadal men with type 2 diabetes. Diab Vasc Dis Res. 2008 Jun;5(2):135-7. doi: 10.3132/dvdr.2008.022. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary pioglitazone effect on testosterone level three months Yes
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