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

NCT06754878 | Not Yet Recruiting

• 1 other identifier: Mg level DFU associated DN
• Study Type: observational
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Serum Magnesium level

  Assessment Of Serum Magnesium level in type II diabetes patients

  baseline

Study Arms (3)

group A

patients diagnosed as diabetic type 2 without complications

group B

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

group C

Healthy control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic type 2 Patients with complication as Diabetic foot ulceration Diabetic nephropathy CKD patients not on dialysis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Elham Mohamed Mahmoud Mohamed, resident doctor

CONTACT

+201115747016; elhammohammed788@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12