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Effects of Steroid Therapy on Quality of Life and Adverse Health outcomes in Primary Adrenal Insufficiency

Not Applicable
Conditions
Health Condition 1: E271- Primary adrenocortical insufficiency
Registration Number
CTRI/2024/08/072253
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Diagnosed cases of primary adrenal insufficiency including classical CAH of age 18 to 65 years being treated with stable dose of glucocorticoid for last 3 months.

Exclusion Criteria

1.Any secondary cause of adrenal insufficiency.

2. Pregnancy.

3.Chronic disease like CKD, CLD and chronic infections

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quality of life using short-form health survey (SF-36) QoL questionnaire in Primary adrenal insufficiencyTimepoint: outcome will be assessed at baseline, 24 weeks & 48 weeks.
Secondary Outcome Measures
NameTimeMethod
1.To compare the change in cardiometabolic parame-ters (HOMA2IR, adiponectin, leptin, hs-CRP) and bone turnover markers (sclerostin, P1NP, CTX) in PAI patients on hydrocortisone or prednisolone treatment at baseline, 6 month and 1 year. <br/ ><br> <br/ ><br> <br/ ><br>2.To compare the change in lumbar spine BMD and Trabecular bone score (TBS) over 1 year in PAI patients on hydrocortisone or prednisolone replacement therapy. <br/ ><br>3.To compare the change in body composition parameters, include lean body mass, fat mass, fat per-centage and android to gynecoid ratio using bioimpedance analyzer (BIA) and dual energy x-ray absorptiometry (DXA) in patients on hydrocortisone or prednisolone at baseline,6month and 1 year.Timepoint: one year
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