Type 2 Diabetes Mellitus
Conditions
Keywords
eugonadal, testosterone
Brief summary
To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.
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.
Interventions
None listed
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pioglitazone effect on testosterone level | three months |
Countries
India
Contacts
Primary Contactsridhar subbiah, MD medicine
Backup ContactDr anil Bhansoli, MD.DM
Outcome results
None listed