Irisin And Diabetic Nephropathy

NCT05144672 | Unknown

• 1 other identifier: AATHSH
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irisin

Outcome Measures

Primary Outcomes (1)

• The relation between different stages of diabetic nephropathy and irisin level.

  measurement of irisin level in patients with diabetic nephropathy

  1 year

Study Arms (2)

Patient Group

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; Other: Estimated glomerular filtration rate (eGFR)

Control Group

control group will include 30 apparently healthy age-matched and sex-matched individuals.

Other: Anthropometric measurements; Procedure: Electrocardiogram and Fundus examination; Other: Brachial index; Diagnostic Test: Laboratory tests; Radiation: Abdominal ultrasound.

Interventions

Laboratory tests DIAGNOSTIC_TEST

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.

Patient Group

Anthropometric measurements OTHER

Height, weight, waist circumference, and hip circumference were taken as a way of assessing the nutritional status and BMI

Control Group

Electrocardiogram and Fundus examination PROCEDURE

Fundus examination by direct ophthalmoscope

Control Group

Estimated glomerular filtration rate (eGFR) OTHER

Estimated glomerular filtration rate (eGFR) was calculated by EPI equation.

Patient Group

Brachial index OTHER

The ankle-brachial index test compares the blood pressure measured at your ankle with the blood pressure measured at your arm

Control Group

Abdominal ultrasound. RADIATION

It will be performed for patients only.

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy.

You may qualify if:

• Any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 32849950 BACKGROUND

• 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.

  PMID: 33580109 BACKGROUND

• 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.

  PMID: 30641727 BACKGROUND

MeSH Terms

Interventions

Clinical Laboratory Techniques

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Hala Khalah Allah Khalifa El-shereef, MD

CONTACT

01120110000; dr_hala_elshereef@yahoo.com

Marwa Kamal Abdo Khair Allah, MD

CONTACT

01097878113; Marwa.kamal82@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 3, 2021
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 3, 2021

Record last verified: 2021-10