IRAPe, Irisin and IL-34 in Patients With Type 2 Diabetes

Type2 Diabetes Mellitus Clinical Trial

Official title:

Circulating IRAPe, Irisin and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107259
• Other study ID #: IRAPe, Irisin and IL-34
• Status: Completed
• Start date: January 19, 2019
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2020
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus.

Methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio.

Description:

Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus.

Methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio. Anthropometric parameters, blood glucose, fasting plasma insulin, insulin resistance index (HOMA-IR), IL34, Irisin, IRAPe, Visfatin and glycated hemoglobin were assessed.

Conclusion: IL-34 and Visfatin levels were significantly increased, while both Irisin and IRAPe levels were significantly decreased in patients with type 2 diabetes. Theses aforementioned parameters were significantly correlated with insulin resistance. These findings indicate that, IL-34, Irisin and IRAPe may play a vital role in T2DM and in diabetes associated insulin resistance. Additionally, the investigator's findings proposed that, IRAPe may be a useful and direct marker for detection of insulin resistance state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 20, 2019
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• newly diagnosed type 2 diabetes and non-diabetic control subjects from 35 to 65 years old were enrolled in this study.

Exclusion Criteria:

• individuals with inflammatory diseases, Cushing's syndrome, thyroid disorders, infectious diseases, cancers, hepatic diseases and renal impairment. Subjects on insulin or other medications that could affect glucose metabolism or pro-inflammatory cytokines assessment (Glucocorticoids, beta-Adrenergic agonists, Thiazides, etc.....) were also excluded from study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Diagnostic Test:
• Blood sample
Ten ml of venous blood was collected from all participants in the early morning after an overnight 12 hour fast by venipuncture of the antecubital vein into sterile tubes. Plasma and sera were separated immediately and were stored at -70 C until biochemical analyses.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Chang EJ, Lee SK, Song YS, Jang YJ, Park HS, Hong JP, Ko AR, Kim DY, Kim JH, Lee YJ, Heo YS. IL-34 is associated with obesity, chronic inflammation, and insulin resistance. J Clin Endocrinol Metab. 2014 Jul;99(7):E1263-71. doi: 10.1210/jc.2013-4409. Epub — View Citation

Sesti G, Andreozzi F, Fiorentino TV, Mannino GC, Sciacqua A, Marini MA, Perticone F. High circulating irisin levels are associated with insulin resistance and vascular atherosclerosis in a cohort of nondiabetic adult subjects. Acta Diabetol. 2014 Oct;51(5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose (FBG) levels	were assayed using glucose oxidase method.	three months
Primary	Fasting plasma insulin (FPI)	was assayed using Enzyme-Linked Immunosorbent Assay kits i.e ELISA	three months
Primary	HOMA-IR index	HOMA-IR index which is defined as fasting insulin (µIU/ml) times fasting glucose (mg/L) divided by 405 if fasting blood glucose is expressed in mass units (mg/dl).	three months
Primary	plasma IL-34	human plasma IL-34 was assayed using sandwich enzyme immunoassay technique	Three months
Primary	serum visfatin	serum visfatin concentrations enzyme- immunoassay kit	Three Months
Primary	IRAPe	extracellular part of insulin regulated aminopeptidase (IRAPe) level was determined using sandwich enzyme immunoassay technique	Three months