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

NCT04107259 | Completed

• 1 other identifier: IRAPe, Irisin and IL-34
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; IL-34; Irisin; IRAPe; Visfatin; Insulin resistance; HOMA-IR

Outcome Measures

Primary Outcomes (6)

• Fasting blood glucose (FBG) levels

  were assayed using glucose oxidase method.

  three months

• Fasting plasma insulin (FPI)

  was assayed using Enzyme-Linked Immunosorbent Assay kits i.e ELISA

  three months

• 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

• plasma IL-34

  human plasma IL-34 was assayed using sandwich enzyme immunoassay technique

  Three months

• serum visfatin

  serum visfatin concentrations enzyme- immunoassay kit

  Three Months

• IRAPe

  extracellular part of insulin regulated aminopeptidase (IRAPe) level was determined using sandwich enzyme immunoassay technique

  Three months

Study Arms (2)

Patient with diabetes

60 newly diagnosed type 2 diabetes

Diagnostic Test: Blood sample

Control

60 non-diabetic control subjects

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

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.

Control; Patient with diabetes

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (3)

• 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.

  PMID: 24712570 RESULT

• 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.

  PMID: 24619655 RESULT

• 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.

  PMID: 34103176 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tarek Mostafa, Ass Prof.

  Tanta University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: January 19, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 20, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

EG (1)