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临床试验/CTRI/2018/12/016785
CTRI/2018/12/016785招募中不适用

Prevalence of primary aldosteronism in patients with type 2 diabetes mellitus and hypertension: Prospective study from western India

Diamond Jubilee Society Trust Seth GSMC and KEM Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年12月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Prevalence of primary aldosteronism in patients with type 2 diabetes and hypertension

研究概览

简要总结

Protocolsummary:

Primary aldosteronism (PA) is characterized byexcessive secretion of aldosterone from the adrenal gland.  Presence of hyperaldosteronism is associatedwith a worse outcome with respect to end organ damage especially faster rate ofprogression of proteinuria and adverse cardiovascular outcomes. PA is oftenassociated impaired glucose tolerance. The contribution of primaryaldosteronism to hypertension in patients with diabetes has not been wellstudied.  The endocrine society guidelines on management of primary aldosteronismemphasize that people with hypertension should undergo screening given thebeneficial effect of treatment of PA

The study aims at screening patients with diabetes andhypertension for primary aldosteronism. All patients with type 2 diabetes attendingthe diabetes OPD at KEM hospital will be screened for hypertension. Patients withdiabetes who are already on antihypertensive medications will also be included.Patients who refuse consent, who have serious infections, diabetic ketosis,heart failure or another known cause of secondary hypertension will beexcluded. Written informed consent will be taken after ethical clearance. Theidentity of participants will be kept confidential and will be coded forfurther analysis.

A total of 1000 patients will be screened by using PAC/DRCratio as a screening tool. The test involves collection of blood sample after15 minutes of sitting position. In patients with positive results, furtherinvestigations and treatment as is the standard of care will be provided. This mayinclude further repeat testing, confirmatory testing, CT adrenals and AVS ifsurgical management is planned. Further management either medical or surgicalintervention will be offered to the patients according to guidelines.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • History of type 2 diabetes BP 130/80 or on antihypertensives.

排除标准

  • Diabetic ketosis, hyperosmolar non-ketotic syndrome, active infections •heart failure (New York Heart Association class III or IV) •Pregnancy, breastfeeding, use of oral contraceptives, •known primary aldosteronism or a history of pheochromocytoma, Cushing’s syndrome, or hyperthyroidism •No consent.

结局指标

主要结局

Prevalence of primary aldosteronism in patients with type 2 diabetes and hypertension

时间窗: 18 months

次要结局

未报告次要终点

研究者

发起方
Diamond Jubilee Society Trust Seth GSMC and KEM Hospital
申办方类型
Other [Private trust]

研究点 (1)

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