Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Males from 30 years to 65 years of age with Known cases of type 2 diabetes mellitus > 5 years duration with or without obesity.
Exclusion criteria
Exclusion criteria: 1.Use of androgen therapy or anabolic steroids within 12 weeks of entry into the study. 2.History or current diagnosis of breast or prostate cancer. 3.Patients with known causes of hypogonadism (e.g. Klinefelterââ?¬•s syndrome, uncorrected cryptorchidism, surgical orchiectomy, or prior infectious orchitis) 4.T1DM, suffering from any known chronic liver disease, renal disease, advanced malignancy, debilitating diseases such as tuberculosis, malabsorption, inflammatory bowel disease, pyrexia of unknown origin, acquired immunodeficiency syndrome, sickle cell disease, autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, any inflammatory disease or infection, and already receiving hormone replacement therapy or with severe psychological symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of T2DM patients who have HG (300 ng/dL)Timepoint: For Days5to7 and Day9to14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) cases in Percentage of hypogonadal patients T2DM with or without obesity 2) Percentage of hypogonadal cases in T2DM patients (with or without obesity) with different age categories(30-39years,40-49years,years,50-59years,and60-65year 3) Percentage of patients with positive ADAM questionnaire but who have testosterone 3a)300/ng/dl at visit 2 3b)300 ng/dL at Visit 2 and Visit 4 4) Percentage of patients with FSH or LH levels 10 IU/L & FSH or LH levels 2IU/L Timepoint: 1) NIL 2) NIL 3) 3a Days5to7 3b Days5to7 and Days9to14 4) NIL | — |
Countries
India
Contacts
Abbott India Pvt ltd