Health Condition 1: null- Indian Males with Type 2 Diabetes Mellitus who may or may not be suffering with Hypogonadism.
Conditions
Interventions
None listed
Sponsors
MSD Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males between the age of 30 to 59 years (both inclusive), with a confirmed diagnosis of Type-2 diabetes mellitus 2.Each subject must be willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes patients 2.Patients receiving testosterone replacement therapy 3.Patients suffering from any chronic liver disease, renal disease, advanced malignancy, debilitating diseases like tuberculosis, malabsorption, inflammatory bowel disease, pyrexia of unknown origin, AIDS, sickle cell disease, autoimmune diseases like rheumatoid arthritis, ankylosing spondylitis 4.Patients with known causes of hypogonadism including: o Hypergonadotropic hypogonadism or primary hypogonadism: testicular failure due to genetic disorders (e.g., Klinefelterâ??s syndrome), orchitis, trauma, castration, radiation, chemotherapy, or undescended testes o Hypogonadotropic hypogonadism, central hypogonadism, or secondary hypogonadism: patients with gonadotropin deficiency or dysfunction as a result of disease or damage to the hypothalamic-pituitary axis (e.g. Kallmannâ??s syndrome, tumour, trauma, radiation, sarcoidosis, or tuberculosis). 5.Patients on medications, or have taken medications in last 6 months, known to cause hypogonadal states like ketoconazole, anabolic steroids, corticosteroids, spironolactone, cimetidine, phenytoin, GnRH analogue, flutamide and narcotic addicts (heroin). 6.Patients having severe psychological symptoms 7.Patients currently enrolled in another clinical trial 8.Patients having any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Prevalence rate of Hypogonadism in patients of type-2 diabetes mellitus â?¢ Prevalence rate of Hypogonadism in patients of type-2 diabetes mellitus by age group. Timepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Prevalence rate of primary (hypergonadotropic) and secondary (hypogonadotropic) androgen deficiency in patients with type-2 diabetes mellitus according to age ranges and body mass index ranges independentlyTimepoint: 12 Months;â?¢ Prevalence rate of testosterone deficiency in patients of type-2 diabetes mellitus â?¢ Effect of age, BMI, and HbA1C levels on testosterone deficiency â?¢ Serum gonadal hormone levels (total testosterone, free testosterone, SHBG, LH, FSH, prolactin, oestradiol) among testosterone deficient patients, according to age ranges and body mass index ranges independently Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactDr Raeesuddin Syed
MSD Pharmaceuticals Pvt. Ltd - Subsidiary of Merck & Co. Inc., Whitehouse Station, N.J. U.S.A.
Outcome results
None listed