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
  Purpose

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


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • pioglitazone effect on testosterone level [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
pioglitazone vs placebo
15 patients in pioglitazone group and 15 in placebo group

Detailed 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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

30 eugonadal men with type 2 diabetes mellitus

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206400

Contacts
Contact: sridhar subbiah, MD medicine 9914411026 drsridharjipmer@gmail.com
Contact: Dr anil Bhansoli, MD.DM 9316977995 anilbhansali_endocrine@rediffmail.com

Locations
India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Dr sridhar subbiah, MD    9914411026    drsridharjipmer@gmail.com   
Principal Investigator: Dr Anil Bhansali, MD.DM         
Principal Investigator: Dr ANil Bhansali, MD.DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Study Chair: Dr. Anil Bhansoli, MD.DM PGIMER,Chandigarh
  More Information

Publications:
Responsible Party: Dr SRIDHAR, PGIMER
ClinicalTrials.gov Identifier: NCT01206400     History of Changes
Other Study ID Numbers: pioglitazonetestosterone
Study First Received: September 20, 2010
Last Updated: June 28, 2011
Health Authority: India:Ministry of health and family welfare

Keywords provided by Postgraduate Institute of Medical Education and Research:
eugonadal, testosterone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Pioglitazone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 28, 2014