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临床试验/CTRI/2024/08/072253
CTRI/2024/08/072253尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Quality of life using short-form health survey (SF-36) QoL questionnaire in Primary adrenal insufficiency

研究概览

简要总结

: 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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 1.Any secondary cause of adrenal insufficiency.
  • 3.Chronic disease like CKD, CLD and chronic infections.

结局指标

主要结局

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

时间窗: outcome will be assessed at baseline, 24 weeks & 48 weeks.

次要结局

  • 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.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mukesh kumar

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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