Prevalence of primary aldosteronism in patients with type 2 diabetes mellitus and hypertension: Prospective study from western India
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Prevalence of primary aldosteronism in patients with type 2 diabetes and hypertension
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •History of type 2 diabetes BP 130/80 or on antihypertensives.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Prevalence of primary aldosteronism in patients with type 2 diabetes and hypertension
Time Frame: 18 months
Secondary Outcomes
No secondary outcomes reported