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

NCT ID: NCT01206400

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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eugonadal, testosterone

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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pioglitazone vs placebo

15 patients in pioglitazone group and 15 in placebo group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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PGIMER

Principal Investigators

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Dr. Anil Bhansoli, MD.DM

Role: STUDY_CHAIR

PGIMER,Chandigarh

Locations

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PGIMER

Chandigarh, Chandigarh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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sridhar subbiah, MD medicine

Role: CONTACT

Phone: 9914411026

Email: [email protected]

Dr anil Bhansoli, MD.DM

Role: CONTACT

Phone: 9316977995

Email: [email protected]

Facility Contacts

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Dr sridhar subbiah, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18537102 (View on PubMed)

Other Identifiers

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pioglitazonetestosterone

Identifier Type: -

Identifier Source: org_study_id