Assessment of Serum Magnesium Level with Diabetic Foot Ulceration in Type II Diabetes Associated with Diabetic Nephropathy Patients

NCT ID: NCT06754878

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-01

Brief Summary

Magnesium (Mg), is the fourth most common cation in the body, with an essential role in fundamental biological reactions, whose deficiency provokes biochemical and symptomatic alterations in the human organism. This ion is now established as a central electrolyte in a large number of cellular metabolic reactions, including DNA and protein synthesis, neurotransmission, and hormone receptor binding. It is a component of GTPase and a cofactor for Na+/ K +-ATPase, adenylate cyclase, and phosphofructokinase. Magnesium is a cofactor in more than 300 cellular enzymatic systems and has a key role in cellular metabolism; the recognition that Mg deficiency or excess may be associated with significant clinical consequences has resulted in an increased interest in the utility of serum Mg measurement.

Diabetes mellitus (DM), characterized by metabolic disorders related to high levels of serum glucose, is probably the most associated disease to Mg depletion in intra and extra cellular compartments. In several studies reduced magnesium concentrations have been observed in diabetic adults. Hypomagnesemia has been related as a cause of insulin resistance, also being a consequence of hyperglycemia, and when it is chronic leads to the installation of macro and microvascular complications of diabetes, worsening the deficiency of Mg. The association between diabetes mellitus and hypomagnesaemia is compelling for its wide ranging impact on diabetic control and complications. Hypomagnesaemia has been linked to poor glycemic control, coronary artery diseases, hypertension, foot ulceration and diabetic neuropathy . Nerve Conduction Test (NCS)is the gold standard test that should be performed to confirm the presence of neuropathy to determine it's severity and to differentiate other causes of neuropathy from diabetic neuropathy.

Detailed Description

Magnesium (Mg), is the fourth most common cation in the body, with an essential role in fundamental biological reactions, whose deficiency provokes biochemical and symptomatic alterations in the human organism. This ion is now established as a central electrolyte in a large number of cellular metabolic reactions, including DNA and protein synthesis, neurotransmission, and hormone receptor binding. It is a component of GTPase and a cofactor for Na+/ K +-ATPase, adenylate cyclase, and phosphofructokinase. Magnesium is a cofactor in more than 300 cellular enzymatic systems and has a key role in cellular metabolism; the recognition that Mg deficiency or excess may be associated with significant clinical consequences has resulted in an increased interest in the utility of serum Mg measurement.

Diabetes mellitus (DM), characterized by metabolic disorders related to high levels of serum glucose, is probably the most associated disease to Mg depletion in intra and extra cellular compartments. In several studies reduced magnesium concentrations have been observed in diabetic adults. Hypomagnesemia has been related as a cause of insulin resistance, also being a consequence of hyperglycemia, and when it is chronic leads to the installation of macro and microvascular complications of diabetes, worsening the deficiency of Mg. The association between diabetes mellitus and hypomagnesaemia is compelling for its wide ranging impact on diabetic control and complications. Hypomagnesaemia has been linked to poor glycemic control, coronary artery diseases, hypertension, foot ulceration and diabetic neuropathy . Nerve Conduction Test (NCS)is the gold standard test that should be performed to confirm the presence of neuropathy to determine it's severity and to differentiate other causes of neuropathy from diabetic neuropathy.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

group A

patients diagnosed as diabetic type 2 without complications

No interventions assigned to this group

group B

patients diagnosed as diabetic type 2 with complications,it was 1.91±0.12

No interventions assigned to this group

group C

Healthy control group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• age>18 years<60 years Diabetic type 2 Patients with Diabetic foot ulceration Diabetic nephropathy CKD patients not on dialysis

Exclusion Criteria

• • Patients with recent infectious disease, immunological disorders, taking diuretics and magnesium containing antacids

• malabsorption syndrome, chronic diarrhea
• CKD Stage V on dialysis, pancreatitis, alcoholism, liver diseases
• tuberculosis, thyrotoxicosis, any malignancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Elham Mohamed Mahmoud Mohamed

resident doctor at Assiut University hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elham Mohamed Mahmoud Mohamed, resident doctor

Role: CONTACT

elhammohammed788@gmail.com

+201115747016

Other Identifiers

Mg level DFU associated DN

Identifier Type: -

Identifier Source: org_study_id