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NCT Number: NCT06754878

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum Magnesium level

    Time frame: baseline

    Assessment Of Serum Magnesium level in type II diabetes patients

Study contacts

Contact information is provided by the study sponsor or research team.

Elham Mohamed Mahmoud Mohamed, resident doctor

CONTACT

[email protected]

+201115747016

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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