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

A Prospective, Multicentric Study to Evaluate the Prevalence of Hypogonadism in Indian Male Patients Suffering from Type 2 Diabetes with or without Obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/032544
Enrollment
600
Registered
2021-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIL: NIL

Sponsors

Abbott Healthcare Pvt Ltd
Lead Sponsor

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

MeasureTime frame
Percentage of T2DM patients who have HG (300 ng/dL)Timepoint: For Days5to7 and Day9to14

Secondary

MeasureTime 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

Public ContactSneha Nair

Abbott India Pvt ltd

kalpesh.gawand@abbott.com9820928987

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026