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Clinical Trials/CTRI/2024/08/072253
CTRI/2024/08/072253
Not yet recruiting
Not Applicable

Comparison of effects of hydrocortisone and prednisolone re-placement therapy on quality of life, metabolic and bone health parameters in primary adrenal insufficiency -an open-label parallel arm randomized controlled trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 site in 1 country60 target enrollmentStarted: August 16, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Quality of life using short-form health survey (SF-36) QoL questionnaire in Primary adrenal insufficiency

Overview

Brief Summary

: Hydrocortisone and prednisolone are the preferred agents for treating primary adrenal insufficiency (PAI). Hydrocortisone is still the preferred agent used to treat PAI. However, endocrinologists lack consensus regarding the impact of different steroid regimens on quality of life, cardiometabolic outcome, and bone health. Despite this preference, some studies have suggested that prednisolone may be as effective as hydrocortisone in managing primary adrenal insufficiency with fewer adverse hypertension, weight gain, and decreased BMD. There is a lack of randomized controlled trials comparing the two medications in terms of their effects on cardiometabolic risk factors, body composition parameters, bone turnover markers, and quality of life.

Novelty: To the best of our knowledge, there is no prior literature from India studying the effect of hydrocortisone and prednisolone replacement therapy on quality of life, cardiometabolic and bone health in primary adrenal insufficiency

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

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.
  • 3.Chronic disease like CKD, CLD and chronic infections.

Outcomes

Primary Outcomes

Quality of life using short-form health survey (SF-36) QoL questionnaire in Primary adrenal insufficiency

Time Frame: outcome will be assessed at baseline, 24 weeks & 48 weeks.

Secondary Outcomes

  • 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.

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Mukesh kumar

Jawaharlal Institute of Postgraduate Medical Education and Research

Study Sites (1)

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