An Observational study to evaluate the Prevalence of Hypogonadism in Indian male patients suffering from T2DM with or wothout Obesity.

Not Applicable

Completed

Conditions: Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere

Registration Number: CTRI/2021/04/032544

Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 600

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

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. KlinefelterÃ¢â?¬•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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of T2DM patients who have HG (300 ng/dL)Timepoint: For Days5to7 and Day9to14

Secondary Outcome Measures

Name	Time	Method
1) cases in Percentage of hypogonadal patients T2DM with or without obesity <br/ ><br>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 <br/ ><br>3) Percentage of patients with positive ADAM questionnaire but who have testosterone <br/ ><br>3a)300/ng/dl at visit 2 <br/ ><br>3b)300 ng/dL at Visit 2 <br/ ><br> and Visit 4 <br/ ><br>4) Percentage of patients with FSH or LH levels 10 IU/L & FSH or LH levels 2IU/L <br/ ><br> <br/ ><br>Timepoint: 1) NIL <br/ ><br>2) NIL <br/ ><br>3) 3a Days5to7 3b Days5to7 and Days9to14 <br/ ><br>4) NI