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

Completed

• Conditions: Type2 Diabetes Mellitus
• Interventions: Diagnostic Test: Blood sample

• Registration Number: NCT04107259
• Lead Sponsor: Damanhour University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-19
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-20
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with diabetes	Blood sample	60 newly diagnosed type 2 diabetes
Control	Blood sample	60 non-diabetic control subjects

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose (FBG) levels	three months	were assayed using glucose oxidase method.
HOMA-IR index	three months	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).
IRAPe	Three months	extracellular part of insulin regulated aminopeptidase (IRAPe) level was determined using sandwich enzyme immunoassay technique
Fasting plasma insulin (FPI)	three months	was assayed using Enzyme-Linked Immunosorbent Assay kits i.e ELISA
plasma IL-34	Three months	human plasma IL-34 was assayed using sandwich enzyme immunoassay technique
serum visfatin	Three Months	serum visfatin concentrations enzyme- immunoassay kit

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt