Diabetes & Obesity International Journal (DOIJ)

ISSN: 2574-7770

Research Article

Prevalence of Primary Aldosteronism and Complications in Type 2 Diabetes Mellitus Patients with Resistant Hypertension: A Prospective Observational Single Centre Study Protocol

Authors: Shadangi S, Sanyal D* and Biswas A

DOI: 10.23880/doij-16000285


Primary hyperaldosteronism (PA) has been thought to be an uncommon cause of hypertension, with an estimated prevalence of 2% among the general hypertensive population but is much higher, especially in resistant hypertension (RH) patients. Recent studies, however, have suggested that the prevalence of PA may be as high as 30% in RH populations. PA is associated with higher morbidity rates than matched essential hypertension patients. RH is more common in type 2 diabetes mellitus (T2DM). PA is generally remediable by treatment with an aldosterone antagonist or, in the case of adrenal adenoma, by adrenalectomy, knowing the true prevalence of PA is important for early diagnosis and treatment. Aim: This study aims to evaluate the prevalence of PA and cardiovascular (CVD) and renal complications in T2DM mellitus patients with resistant hypertension. Method: Prospective observational single centre study, in outpatient (OPD) settings in a tertiary care hospital. The primary outcome of the study is to estimate the prevalence of primary aldosteronism in T2DM patients with resistant hypertension. The secondary outcome is to evaluate the difference in prevalence of complications / comorbidities like CVD, left ventricle hypertrophy(LVH) , atrial fibrillation (AF), chronic kidney disease (CKD) in T2DM patients with and without PA hyperaldosteronism. T2DM patients aged more than 18 years with RH will be included in the study. Patients with type 1 diabetes mellitus or secondary causes of diabetes mellitus, acute diabetic complications, severe underlying systemic diseases, chronic kidney disease stage ≥4 , known secondary causes of hypertension, pregnancy and lactation and on medications like oral contraceptives, spironolactone, eplerenone, amiloride, triamterene will be excluded. Study subjects with plasma aldosterone to renin ratio of value ≥ 1.6 ng/dl/μIU/ml and plasma aldosterone concentration (PAC) of value ≥ 10 ng/dl with suppressed renin, will be considered to be positive on a screening test. Patients, those positive on a screening test will undergo seated saline suppression test (SST). Repeat plasma aldosterone concentration (PAC) with value ≥ 6 ng/dl will be confirmatory test for PA. Conclusion: RH specially in T2DM high-risk phenotype, which may be further aggravated by underlying PA . Thus we want to estimate the prevalence of PA in T2DM patients with RH. We also want to highlight any difference in prevalence of CV and renal complications due to in T2DM patients with and without PA, which may support early screening and diagnosis of PA and targeted treatment of PA to prevent its aggravating effects on chronic diabetes complications.

Keywords: T2DM; Primary Aldosteronism; Chronic Kidney Disease

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