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
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
Mukesh kumar
Jawaharlal Institute of Postgraduate Medical Education and Research