Clinical trial NCT05791188: Electrolyte Disorders in Prediabetics and in Patients With Type 2 Diabetes Mellitus
Official title: Electrolyte Disorders in Prediabetics and in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus and Electrolyte Disorders
Keywords: electrolytes diabetes mellitus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prediabetics

Diabetic patients (type 2 diabetes mellitus) without complications

Diabetic patients (type 2diabetes mellitus) with complications

Controls

Brief summary: The aim of the study is to assess serum sodium \[Na+\], potassium \[K+\] magnesium \[Mg2+\], calcium \[Ca2+\], and chloride \[Cl-\] levels in patients who are prediabetic, diabetics and diabetic with complications (Diabetes mellitus type 2)

Detailed description: Diabetes mellitus is a chronic disease that imposes enormous socioeconomic burdens attributable to complications of various bodily systems. Diabetes affected 463 million people (9.3% of all people) in 2019 and will affect 700 million (10.9%) by 2045.

According to the International Diabetes Federation (IDF), the prevalence of diabetes mellitus among Egyptian adults is 15.2%, which may be an underestimation. Therefore, diabetes mellitus should be thoroughly explored in terms of its risk factors, prevention, treatment, and consequences. Moreover, the general population should be aware of and well informed about all aspects of diabetes.

Prediabetes is a precursor before the diagnosis of diabetes mellitus. Adults with prediabetes often may show no signs or symptoms of diabetes but will have blood glucose levels higher than normal. The normal blood glucose level is between 70 - 99 mg/dL. In patients with prediabetes, the blood glucose levels elevated between 110 - 125 mg/dL.

Once the patient is diagnosed as prediabetes, he should be checked for progression to type 2 diabetes every one to two years. So early detection of prediabetes and so lifestyle changes through improved nutrition and physical activity are the first line treatment for preventing the transition from prediabetes to diabetes which can be as high as 70%.

A normal HbA1C level is below 5.7%, a level of 5.7-6.4% indicates prediabetes, and a level of 6.5% or more indicates diabetes. Within the 5.7-6.4% prediabetes range, the higher HbA1C, the greater risk is for developing type 2 diabetes.

Serum electrolytes are important cofactors for multiple enzymes and play a pivotal role in many key biological and physiological processes, including glucose metabolism. The excess or deficiency of these electrolytes was found to be linked to deleterious metabolism status.

Diabetic patients frequently develop a constellation of electrolyte disorders. These disturbances are particularly common in decompensated diabetics, especially in the context of diabetic ketoacidosis or nonketotic hyperglycemic hyperosmolar syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients with prediabetes who will be diagnosed by:

  * Glycated hemoglobin (HbA1C) test (6.1 - 6.4%) on two separate tests
  * Fasting blood sugar test 110-125 mg/dL (5.6 - 6.9 mmol/L) on two separate tests.
  * Glucose tolerance test 140 - 179 mg/dL (7.8 - 9.9 mmol/L)
* Patients with Type 2 diabetes who will be diagnosed by:

  * Glycated hemoglobin (HbA1C) test ≥ 6.5% on two separate tests
  * Fasting blood sugar test ≥ 126 mg/dL (7 mmol/L) on two separate tests
  * Glucose tolerance test ≥ 200 mg/dL (11.1 mmol/L)
  * Random blood sugar test ≥ 200 mg/dL (11.1 mmol/L)
* Patients with diabetic complications (nephropathy, neuropathy, cardiovascular, retinopathy, metabolic disorders, diabetic ketoacidosis)

Exclusion Criteria:

• Patients with Type 1 diabetes

Primary outcomes:
measure: Serum sodium
timeFrame: baseline
measure: Serum potassium
timeFrame: baseline
measure: Serum magnesium
timeFrame: baseline
measure: Serum calcium
timeFrame: baseline
measure: Serum chloride
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Faisal El-Adawy, Lecturer
role: STUDY_DIRECTOR
References:
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citation: Kieboom BCT, Ligthart S, Dehghan A, Kurstjens S, de Baaij JHF, Franco OH, Hofman A, Zietse R, Stricker BH, Hoorn EJ. Serum magnesium and the risk of prediabetes: a population-based cohort study. Diabetologia. 2017 May;60(5):843-853. doi: 10.1007/s00125-017-4224-4. Epub 2017 Feb 21.
citation: Alvarez S, Coffey R, Mathias PM, Algotar AM. Prediabetes. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459332/