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

NCT04942119 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-06-28

No results posted yet for this study

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.

Conditions

  • Diabetic Kidney Disease
  • Potassium Imbalance
  • Magnesium Deficiency

Interventions

OTHER

Multifactorial intervention

1. Correction of magnesium and/or potassium deficit and the underlying disease. 2. Education reinforcing optimal diet and exercise, in addition to, post-nutrition assessment , diabetes self-care activities and adherence will be given at each follow up visit by a specialized dietitian. 3. Comprehensive medication therapy management by clinical pharmacist, and medication adherence will be measured by adherence questionnaire as well as fixed medication possession ratio (FMPR).

Sponsors & Collaborators

  • United Arab Emirates University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-05-01
Completion
2022-08-01

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04942119 on ClinicalTrials.gov