Irisin And Diabetic Nephropathy

Irisin Clinical Trial

Official title:

Irisin Level in Patients With Diabetic Nephropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05144672
• Other study ID #: AATHSH
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Hala Khalah Allah Khalifa El-shereef, MD
• Phone: 01120110000
• Email: dr_hala_elshereef[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Irisin

Intervention

Diagnostic Test:
• Laboratory tests
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.

Other:
• Anthropometric measurements
Height, weight, waist circumference, and hip circumference were taken as a way of assessing the nutritional status and BMI

Procedure:
• Electrocardiogram and Fundus examination
Fundus examination by direct ophthalmoscope

Other:
• Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) was calculated by EPI equation.
• Brachial index
The ankle-brachial index test compares the blood pressure measured at your ankle with the blood pressure measured at your arm

Diagnostic Test:
• Laboratory tests
Glycosylated haemoglobin. ACR,urinary albumin (mg) and creatinine (g).

Radiation:
• Abdominal ultrasound.
It will be performed for patients only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Ravaut M, Sadeghi H, Leung KK, Volkovs M, Kornas K, Harish V, Watson T, Lewis GF, Weisman A, Poutanen T, Rosella L. Predicting adverse outcomes due to diabetes complications with machine learning using administrative health data. NPJ Digit Med. 2021 Feb 12;4(1):24. doi: 10.1038/s41746-021-00394-8. — View Citation

Tan SY, Mei Wong JL, Sim YJ, Wong SS, Mohamed Elhassan SA, Tan SH, Ling Lim GP, Rong Tay NW, Annan NC, Bhattamisra SK, Candasamy M. Type 1 and 2 diabetes mellitus: A review on current treatment approach and gene therapy as potential intervention. Diabetes Metab Syndr. 2019 Jan - Feb;13(1):364-372. doi: 10.1016/j.dsx.2018.10.008. Epub 2018 Oct 10. Review. — View Citation

Xuan X, Lin J, Zhang Y, Zhou L, Xu L, Jia J, Zhao B, Lin Z, Zhu Q, Li L, Wu T, Zhang S, Jiang H, Wang Y. Serum Irisin Levels and Clinical Implication in Elderly Patients With Type 2 Diabetes Mellitus. J Clin Med Res. 2020 Sep;12(9):612-617. doi: 10.14740/jocmr4261. Epub 2020 Aug 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relation between different stages of diabetic nephropathy and irisin level.	measurement of irisin level in patients with diabetic nephropathy	1 year