NCT01206400

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 30, 2011

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

September 20, 2010

Last Update Submit

June 28, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

eugonadal, testosterone

Outcome Measures

Primary Outcomes (1)

  • pioglitazone effect on testosterone level

    three months

Study Arms (1)

pioglitazone vs placebo

15 patients in pioglitazone group and 15 in placebo group

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

30 eugonadal men with type 2 diabetes mellitus

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related 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.

    PMID: 18537102BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dr. Anil Bhansoli, MD.DM

    PGIMER,Chandigarh

    STUDY CHAIR

Central Study Contacts

sridhar subbiah, MD medicine

CONTACT

9914411026drsridharjipmer@gmail.com

Dr anil Bhansoli, MD.DM

CONTACT

9316977995anilbhansali_endocrine@rediffmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

June 30, 2011

Record last verified: 2010-09

Locations

IN(1)