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

NCT ID: NCT05791188

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus and Electrolyte Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1- Prediabetics

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)

No interventions assigned to this group

2- Diabetic patients without complications

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)

No interventions assigned to this group

3- Diabetic patients with complications

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

No interventions assigned to this group

4- Controls

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mostafa Saad

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Faisal El-Adawy, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ahmed Mostafa Saad, MBBChB

Role: CONTACT

01005852532 ext. 002

Alaa El-Din Abdel-Moniem El-Sayed, Professor

Role: CONTACT

01112732730 ext. 002

References

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Choi JH, Kim HR, Song KH. Musculoskeletal complications in patients with diabetes mellitus. Korean J Intern Med. 2022 Nov;37(6):1099-1110. doi: 10.3904/kjim.2022.168. Epub 2022 Oct 27.

Reference Type BACKGROUND
PMID: 36300322 (View on PubMed)

Abouzid MR, Ali K, Elkhawas I, Elshafei SM. An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus. 2022 Jul 20;14(7):e27066. doi: 10.7759/cureus.27066. eCollection 2022 Jul.

Reference Type BACKGROUND
PMID: 36000101 (View on PubMed)

Eshak ES, Iso H, Maruyama K, Muraki I, Tamakoshi A. Associations between dietary intakes of iron, copper and zinc with risk of type 2 diabetes mellitus: A large population-based prospective cohort study. Clin Nutr. 2018 Apr;37(2):667-674. doi: 10.1016/j.clnu.2017.02.010. Epub 2017 Feb 28.

Reference Type BACKGROUND
PMID: 28285974 (View on PubMed)

Liamis G, Liberopoulos E, Barkas F, Elisaf M. Diabetes mellitus and electrolyte disorders. World J Clin Cases. 2014 Oct 16;2(10):488-96. doi: 10.12998/wjcc.v2.i10.488.

Reference Type BACKGROUND
PMID: 25325058 (View on PubMed)

Hou Y, Xiang J, Dai H, Wang T, Li M, Lin H, Wang S, Xu Y, Lu J, Chen Y, Wang W, Ning G, Zhao Z, Bi Y, Xu M. New clusters of serum electrolytes aid in stratification of diabetes and metabolic risk. J Diabetes. 2022 Feb;14(2):121-133. doi: 10.1111/1753-0407.13244. Epub 2021 Dec 28.

Reference Type BACKGROUND
PMID: 34963041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28224192 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 29083606 (View on PubMed)

Other Identifiers

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Electrolytes Diabetes Mellitus

Identifier Type: -

Identifier Source: org_study_id

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