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临床试验/NCT05791188
NCT05791188尚未招募不适用

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

Assiut University0 个研究点目标入组 200 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Serum sodium

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Patients with Type 1 diabetes

结局指标

主要结局

Serum sodium

时间窗: baseline

assessment of serum sodium \[Na+\] in prediabetic and diabetic patients compared with controls

Serum potassium

时间窗: baseline

assessment of serum potassium \[K+\] in prediabetic and diabetic patients compared with controls

Serum magnesium

时间窗: baseline

assessment of serum magnesium \[Mg2+\] in prediabetic and diabetic patients compared with controls

Serum calcium

时间窗: baseline

assessment of serum calcium \[Ca2+\] in prediabetic and diabetic patients compared with controls

Serum chloride

时间窗: baseline

assessment of serum chloride \[Cl-\] in prediabetic and diabetic patients compared with controls

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mostafa Saad

Doctor

Assiut University

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