Electrolyte Disorders in Prediabetics and in Patients With Type 2 Diabetes Mellitus

Assiut University

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus and Electrolyte Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT05791188

Electrolytes Diabetes Mellitus

Details and patient eligibility

About

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)

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

1- Prediabetics

Description:

Prediabetics who will be diagnosed by: Glycated hemoglobin (HbA1C) test 5.7 - 6.4% % on two separate tests Fasting blood sugar test 110-125 mg/dL (6.1 - 6.9 mmol/L) on two separate tests. Glucose tolerance test 140 - 179 mg/dL (7.8 - 9.9 mmol/L)

2- Diabetic patients without complications

Description:

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)

3- Diabetic patients with complications

Description:

Diabetic patients with complications (nephropathy, neuropathy, cardiovascular, retinopathy, metabolic disorders, diabetic ketoacidosis)

4- Controls

Description:

apparently normal subjects who have matched age and sex with patients groups