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

NCT04942119 | Unknown DMC

• 1 other identifier: SEHA-IRB-021
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic kidney disease, Magnesium, Potassium, medication adherence, diet adherence, mobile application, fixed medication possession ratio.

Outcome Measures

Primary Outcomes (5)

• Difference in eGFR

  Difference in eGFR based on Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) and the progression to mild albuminuria.

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

• Serum potassium and magnesium levels

  The mean variation of serum potassium and magnesium levels from baseline data.

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

• Medication adherence

  Change of medication adherence measured by the fixed medication possession ratio (FMPR) equation and confirmed by medication adherence questionnaire. Patient's medication refills will be recorded in each visit and the standard adherence threshold of 0.80 MPR will be used as upper bound for mediation adherence, with MPR= 1 means perfect adherence. While an MPR \< 0.50 indicates patient non-adherence, and MPR=0 means no adherence.

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

• Dietary adherence

  Assessment will utilize the revised Summary of Diabetes Self-Care Activities (SDSCA) scale using the metric "days per week" instead of using percentages and will cover diabetes self-care activities and adherence to the prescribed supplements during the past 7 days.

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

• Lifestyle adherence

  Baseline exercise counseling by our specialized dietitian, conducted for 30 minutes at initial visit upon recruitment. Reinforcing optimal exercise level will be given at each follow up visit, with exercise post- assessment questionnaire, having 2 exercise core set questions from SDSCA scale.

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

Secondary Outcomes (3)

• HbA1c level

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

• Optimal electrolyte levels and metabolic panel

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

• Side effects or complications

  From date of randomization until the end of the follow-up period or date of participant exit for any cause, whichever came first, assessed up to 12 months (during the study follow-up period)

Study Arms (2)

Routine standard care group

NO INTERVENTION

This group will continue to receive the usual recommended care provided in the clinic and usual follow-up appointment as well as clinical assessment. Any required nutrition education by the dietitian or medication counseling will be provided at any visit or when requested.

Multifactorial intervention group

EXPERIMENTAL

1. Correction of magnesium and/or potassium levels, and correction of the underlying disease, if possible by a endocrinologist. 2. Education at each follow-up visit by a specialized dietitian, reinforcing optimal diet and exercise, with pre-\& post-nutrition and physical activity assessment using the validated revised summary of diabetes self-care activities (SDSCA) scale. 3. Medication reconciliation and counseling, online post adherence questionnaire and confirm adherence by fixed medication possession ratio (FMPR) approach.

Other: Multifactorial intervention

Interventions

Multifactorial intervention OTHER

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).

Multifactorial intervention group

Eligibility Criteria

• Age: 30 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female UAE citizen patients between 30 and 60 years of age.
• Patient has been previously diagnosed with type 2 diabetes mellitus recorded in Cerner, defined by diabetes mellitus in our diagnostic criteria
• Previously on diabetic medication recorded in Cerner and antidiabetic therapy must be unchanged for 12 weeks prior to the study.
• Patients with normal or mild to moderate magnesium and / or potassium serum levels, as defined in our definition.
• Patients with normal or mild impaired renal function, defined as glomerular filtration rate more than 30 ml/min and albumin/creatinine ratio ≤ 30 mg/mmol, for more than 3 months as baseline value (Stage G1, G2, G3a and G3b of chronic kidney disease (CKD).
• Body Mass index less than 40 at study enrollment.

You may not qualify if:

• Non-UAE citizen patients or patients without full insurance coverage.
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell population (e.g., malaria, babesiosis, hemolytic anemia).
• Patients with severe or symptomatic hypokalemia and/or hypomagnesemia, metabolic acidosis, or hypophosphatemia with or without proximal renal tubular acidosis and Fanconi syndrome, as defined in our definition.
• Prolonged hypokalemia with surreptitious diuretic use, laxative abuse, eating disorders, or primary aldosteronism.
• Stage 4 or 5 CKD patients, with severe reduction in glomerular filtration rate, kidney failure or dialysis, defined as GFR ≤ 29 ml/min or albumin/creatinine ratio ˃ 30 mg/mmol as baseline value.
• High cardiovascular risk (defined as 10-year predicted ASCVD risk ≥7.5% by Pooled Cohort Equation or Framingham Risk Score ≥20%), or cardiac surgery, or angioplasty within the last 12 months or any diabetic macrovascular complications as defined in our definition.
• Receiving medication that may cause drug-induced acute renal failure during the observational period and may be implicated in hypomagnesemia (such as aminoglycoside antibiotics, cyclosporine, amphotericin B, cisplatin, pentamidine, and foscarnet).
• Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) as determined at the beginning of the study or within the last 12 months.
• Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
• Medical history of cancer and/or treatment for cancer within the last 5 years, or immune compromised patients.
• Treatment with systemic steroids or change in dosage of thyroid hormones within the last 12 months after starting the study or any other uncontrolled endocrine disorder.
• Pre-menopausal women who are nursing or pregnant within the last 12 months.
• Patient with communication barriers that may affect obtaining patient's adherence, receiving diet, exercise counseling or consent signing, and include:
• Patients with severe emotional distress.
• Patients who are unable to use mobile applications or to access the internet for any reason.

Sponsors & Collaborators

• United Arab Emirates University: lead

Study Sites (1)

Oud Al Touba Diagnostic and Screening center, AHS, SEHA.

Al Ain City, 00971, United Arab Emirates

RECRUITING

Related Publications (1)

• El-Deyarbi M, Ahmed L, King J, Adi ZS, Al Juboori A, Mansour NA, Al Nuaimi H, Beiram R, Aburuz S. Impact of multifactorial interventions with medication and lifestyle optimization on patients with type 2 diabetes: A randomised controlled trial. PLoS One. 2025 Jul 9;20(7):e0327211. doi: 10.1371/journal.pone.0327211. eCollection 2025.

  PMID: 40632722 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Magnesium Deficiency; Medication Adherence

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Salahdein Aburuz, Prof

CONTACT

+971556169997; saburuz@uaeu.ac.ae

Marwan El-Deyarbi, Msc

CONTACT

+971507936700; mmdeyarbi@seha.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: A randomized, single-blinded, control study of 160 national UAE citizen patients who have been diagnosed with type 2 diabetes mellitus and will attend the endocrinology or chronic disease clinic (CDC) and having follow-up schedules in an ambulatory healthcare services (AHS) clinic, UAE.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 28, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)