Clinical trial NCT04107259: IRAPe, Irisin and IL-34 in Patients With Type 2 Diabetes
Official title: Circulating IRAPe, Irisin and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
IL-34
Irisin
IRAPe
Visfatin
Insulin resistance
HOMA-IR
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2019-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus were diagnosed according to the criteria of the World Health Organization. All individuals included in this study were adult Middle-Eastern Egyptian citizens and were subjected to full medical history and physical examination by hospital physicians.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting blood glucose (FBG) levels
timeFrame: three months
measure: Fasting plasma insulin (FPI)
timeFrame: three months
measure: HOMA-IR index
timeFrame: three months
measure: plasma IL-34
timeFrame: Three months
measure: serum visfatin
timeFrame: Three Months
measure: IRAPe
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
affiliation: Tanta University
name: Tarek Mostafa, Ass Prof.
role: STUDY_CHAIR
References:
citation: 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 2014 Apr 8.
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):705-13. doi: 10.1007/s00592-014-0576-0. Epub 2014 Mar 12.
citation: Mostafa TM, El-Gharbawy NM, Werida RH. Circulating IRAPe, Irisin, and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes. Clin Ther. 2021 Jul;43(7):e230-e240. doi: 10.1016/j.clinthera.2021.05.003. Epub 2021 Jun 5.