Irisin And Diabetic Nephropathy

• Conditions: Irisin
• Interventions: Diagnostic Test: Laboratory tests; Other: Anthropometric measurements; Other: Estimated glomerular filtration rate (eGFR); Procedure: Electrocardiogram and Fundus examination; Other: Brachial index; Radiation: Abdominal ultrasound.

• Registration Number: NCT05144672
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-11-20
• Study First Submitted QC: 2021-11-20
• Last Update Submitted: 2021-11-20
• Study First Posted: 2021-12-03
• Last Update Posted: 2021-12-03
• Study Start: 2022-01-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Group	Laboratory tests	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.
Patient Group	Estimated glomerular filtration rate (eGFR)	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.
Control Group	Abdominal ultrasound.	control group will include 30 apparently healthy age-matched and sex-matched individuals.
Control Group	Brachial index	control group will include 30 apparently healthy age-matched and sex-matched individuals.
Control Group	Laboratory tests	control group will include 30 apparently healthy age-matched and sex-matched individuals.
Control Group	Anthropometric measurements	control group will include 30 apparently healthy age-matched and sex-matched individuals.
Control Group	Electrocardiogram and Fundus examination	control group will include 30 apparently healthy age-matched and sex-matched individuals.

Primary Outcome Measures

Name	Time	Method
The relation between different stages of diabetic nephropathy and irisin level.	1 year	measurement of irisin level in patients with diabetic nephropathy