Impact of Long-term Serum Magnesium and Potassium Levels Optimization and Multifactorial Adherence Intervention on the Progression of Diabetic Kidney Disease.

Diabetic Kidney Disease Clinical Trial

Official title: Impact of Long-term Serum Magnesium and Potassium Levels Optimization and Multifactorial Adherence Intervention on the Progression of Diabetic Kidney Disease.

Status Recruiting

Clinical Trial Summary

Insufficient clinical evidence correlates the progression of diabetic kidney disease with electrolyte homeostasis in patients diagnosed with type 2 diabetes mellitus (T2DM), especially in the United Arab Emirates (UAE) population and what are the most effective interventions to slow chronic renal failure progression.

In our research, we test the hypothesis that low serum magnesium and potassium levels are directly associated with the decline of kidney function in diabetic patients who did not have severely impaired renal function at baseline. In addition, we describe the effect of long-term multifactorial adherence interventions on medication adherence, diet adherence and follow-up visits using a telemedicine approach such as mobile applications in reducing the progression of chronic kidney disease and other diabetes-related complications.

This study is a single-blind randomized control trial to demonstrate the causal relationship between potassium and magnesium levels and estimated glomerular filtration rate (eGFR) decline. The intervention group will be evaluated for manifestations of electrolyte imbalance and correction of serum magnesium and/or potassium levels will be initiated based on the last updated laboratory test. Moreover, they will receive education to reinforce diet and exercise changes at each follow up visit by a specialized dietitian with pharmacist-led comprehensive medication therapy management utilizing multifactorial adherence interventions to measure potential drug-drug or drug-food interactions, as well as medication and follow-up adherence through an integrated mobile application and fixed medication possession ratio (FMPR).

This research is under progress, and summary of its findings will be reported. This study will suggest if additional national monitoring guidelines may be warranted. In addition, it will reduce diabetic burden, medication cost in UAE and improve patient satisfaction by reducing or delaying the progression of diabetic kidney disease in diabetic patients.

Clinical Trial Description

Some studies showed that electrolyte homeostasis is altered in diabetic patients compared with non-diabetic patients even in normotensive patients. Serum magnesium and sodium concentrations were found to be decreased and potassium and calcium levels to be increased in patients with diabetes mellitus compared to euglycemic patients (Shahid et al., 2008). Other studies showed that hyperglycemia-induced effects on cellular transport processes and the depression of the function of Sodium-potassium ATPase pump (NaK-ATPase) may play a major role in attenuating electrolyte abnormalities in patients with diabetes (Reza, et al., 2015).

Limited studies were conducted recently to investigate the effectiveness of correcting electrolyte imbalances, including both serum hypomagnesemia and hypokalemia, in improving patients' symptoms during the recovery from acute renal failure. Form several studies, the authors suggested potential avenues of future research to include investigating the effect of treating hypomagnesemia in conjunction with hypokalemia in kidney disease on the progression of diabetic kidney disease. The encouraging results of the mentioned investigation have, consequently, provoked the interest in optimizing serum magnesium and potassium to delay the progression of chronic kidney disease.

Moreover, this research will examine new dimensions of multifactorial intervention approach to the local population of UAE. The research will include dietitians' interventions to enhance adherence to dietary advice, pharmacist-led interventions to evaluate long-term adherence to medication, as well as follow-up schedule including regular laboratory testing to provide regular monitoring of eGFR, and to ensure that the patients are not receiving contraindicated or inappropriately high dose of medication as their eGFR declines in the progression of diabetic kidney.

Research Objectives The proposed research study aims to investigate the impacts of optimizing potassium and magnesium levels and multifactorial intervention including pharmacist-led medication adherence and optimization with dietary and lifestyle counseling on the progression of diabetic kidney disease and other diabetic metabolic outcomes in patients diagnosed with type 2 diabetes mellitus (T2DM) in national UAE population.

Primary Objectives:

1. To evaluate the impact on the progression of diabetic kidney disease through pharmacist-led medication compliance and optimization, along with dietary, exercise and follow-up visits adherence, using multi-intervention approach.

2. To describe the effect of pharmacist led therapy review and adherence, and dietary counseling on electrolyte levels, specifically potassium and magnesium levels.

3. To establish the relationship between serum potassium and magnesium levels and the progression of diabetic kidney disease.

Secondary objectives

1. To assess the influence of the multifactorial interventions on other diabetic outcomes, such as HbA1c level, and other diabetes-related complications.

2. To measure changes in the patient's metabolic panel and electrolyte levels as a consequence of the multifactorial interventions.

Research Overview

The proposed research will target diabetic patients and the progression of diabetic kidney disease, which is one of the most common chronic diseases among UAE citizens. The rate of progression varies considerably between individuals depending on serum electrolyte levels such as serum magnesium and potassium levels, the conventional or multifactorial intervention received, and determinants of adherence early in the course of diabetic disease. The proposed research will investigate the impact of serum magnesium and potassium levels with long-term multifactorial intervention targeting multiple risk factors and adherence on the progression of diabetic kidney disease in UAE citizen patients with type 2 diabetes. ;

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Magnesium Deficiency
• Potassium Imbalance

• NCT number: NCT04942119
• Study type: Interventional
• Source: United Arab Emirates University
• Contact: Salahdein Aburuz, Prof
• Phone: +971556169997
• Email: saburuz@uaeu.ac.ae
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Completion date: August 1, 2022