Irisin And Diabetic Nephropathy

Study Overview
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Brief Summary
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Diabetes mellitus (DM) is a complex, multifactorial, chronic metabolic and endocrine disorder. It has become a threat to global health. It has two types. It is estimated that the number of people with type II will reach 700 million by 2045.

Detailed Description
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It is associated with acute and chronic complications, acute complications include hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hyperglycemic diabetic coma. Chronic complications are further divided into microvascular and macrovascular complications. Chronic microvascular complications are neuropathy, retinopathy, and nephropathy. The later one firstly diagnosed by microalbuminuria. whereas chronic macrovascular complications are coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease. The conventional medications in diabetes treatment, oral and insulin, are focusing on insulin secretion and insulin sensitisation. Oral antidiabetics include, Biguanides, Sulfonylureas, Thiazolidinediones, DPP4 inhibitors, GLP-1 analogue, and SGLT2 inhibitors. Irisin, a myokin and adipokine secreted by muscles and subcutaneous fat, is an interesting peptide performing significant functions in human health. Irisin has been linked to human obesity and insulin resistance status. Irisin is involved in regulating the mitochondrial function of muscle cells, so increases energy consumption of the body, promotes metabolism and reduces body weight so improves insulin sensetivity. In our study we aim to clarify the effect of antidiabetics on serum irisin in patients with typeII DM who developed diabetic nephropathy.

Official Title
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Irisin Level in Patients With Diabetic Nephropathy

Conditions
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Irisin

Intervention / Treatment
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* Diagnostic Test: Laboratory tests
* Other: Anthropometric measurements
* Procedure: Electrocardiogram and Fundus examination
* Other: Estimated glomerular filtration rate (eGFR)
* Other: Brachial index
* Diagnostic Test: Laboratory tests
* Radiation: Abdominal ultrasound.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy. Exclusion Criteria: Patients below 40 yrs. Patients with type 1 diabetes complicated with diabetic nephropathy Type2 diabetes without nephropathy. Diabetic nephropathy cases on dialysis due to other causes Blood pressure more than 160/100 Acute coronary syndrome in the past 6 months Non alcoholic fatty liver disease, impaired liver function. Malignancy. Pregnancy Acute infection, acute inflammation. Severe renal impairment, and urinary tract infection.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Group<br>The patient group will include 60 patients with type II DM. They will be subdivided into three groups according to albumin-creatinine ratio ,normoalbuminuric group(less than 30mg/g),which will include 20 patients, microalbuminuric group (ACR =30-300 mg/), which will include 20 patients, and macroalbuminuric group (ACR more than 300mg/g),which will include 20 patients. | Diagnostic Test: Laboratory tests<br>* Fasting blood glucose (FBG), postprandial blood glucose, total cholesterol (CHO), triglycerides (TG), high-density lipoprotein cholesterol and low-density lipoprotein cholesterol (LDL-C), urea, creatinine, and uric acid by point colorimetric assay. Serum irisin.<br>Other: Estimated glomerular filtration rate (eGFR)<br>* Estimated glomerular filtration rate (eGFR) was calculated by EPI equation.<br>|
| Control Group<br>control group will include 30 apparently healthy age-matched and sex-matched individuals. | Other: Anthropometric measurements<br>* Height, weight, waist circumference, and hip circumference were taken as a way of assessing the nutritional status and BMI<br>Procedure: Electrocardiogram and Fundus examination<br>* Fundus examination by direct ophthalmoscope<br>Other: Brachial index<br>* The ankle-brachial index test compares the blood pressure measured at your ankle with the blood pressure measured at your arm<br>Diagnostic Test: Laboratory tests<br>* Glycosylated haemoglobin. ACR,urinary albumin (mg) and creatinine (g).<br>Radiation: Abdominal ultrasound.<br>* It will be performed for patients only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between different stages of diabetic nephropathy and irisin level. | measurement of irisin level in patients with diabetic nephropathy | 1 year |