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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01206400
First received: September 20, 2010
Last updated: June 28, 2011
Last verified: September 2010

September 20, 2010
June 28, 2011
September 2010
December 2011   (final data collection date for primary outcome measure)
pioglitazone effect on testosterone level [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01206400 on ClinicalTrials.gov Archive Site
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Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study
Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

30 eugonadal men with type 2 diabetes mellitus

Type 2 Diabetes Mellitus
Not Provided
pioglitazone vs placebo
15 patients in pioglitazone group and 15 in placebo group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
January 2012
December 2011   (final data collection date for primary outcome measure)

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.
Male
25 Years to 50 Years
No
Contact: sridhar subbiah, MD medicine 9914411026 drsridharjipmer@gmail.com
Contact: Dr anil Bhansoli, MD.DM 9316977995 anilbhansali_endocrine@rediffmail.com
India
 
NCT01206400
pioglitazonetestosterone
Yes
Dr SRIDHAR, PGIMER
Postgraduate Institute of Medical Education and Research
Not Provided
Study Chair: Dr. Anil Bhansoli, MD.DM PGIMER,Chandigarh
Postgraduate Institute of Medical Education and Research
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP