NCT04942119

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

Status unknown NA Last updated 28 June 2021

What this trial tests

NA trial testing Multifactorial intervention in Diabetic Kidney Disease in 160 participants. Status unknown.

Timeline

1 May 2021

Primary endpoint
1 May 2022

1 August 2022

Quick facts

Lead sponsor	United Arab Emirates University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	160
Start date	1 May 2021
Primary completion	1 May 2022
Estimated completion	1 August 2022
Sites	1 location across United Arab Emirates

Drugs / interventions tested

• Multifactorial intervention

Conditions studied

• Diabetic Kidney Disease — all drugs for Diabetic Kidney Disease →
• Potassium Imbalance — all drugs for Potassium Imbalance →
• Magnesium Deficiency — all drugs for Magnesium Deficiency →

Sponsor

United Arab Emirates University

Who can join

Adults 30 to 61, any sex, with Diabetic Kidney Disease or Potassium Imbalance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effects of multifactorial pharmacist-led intervention protocol on medication optimisation and adherence among patients with type 2 diabetes: A randomised control trial.
   El-Deyarbi M, Ahmed L, King J, Abubackar S, et al · · 2024 · cited 4× · PMID 39318717 · DOI 10.12688/f1000research.146517.2
2. Impact of multifactorial interventions with medication and lifestyle optimization on patients with type 2 diabetes: A randomised controlled trial.
   El-Deyarbi M, Ahmed L, King J, Adi ZS, et al · · 2025 · PMID 40632722 · DOI 10.1371/journal.pone.0327211