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NCT Number: NCT04107259

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

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.

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Key information

Conditions

Type2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Fasting blood glucose (FBG) levels

    Time frame: three months

    were assayed using glucose oxidase method.

  2. Fasting plasma insulin (FPI)

    Time frame: three months

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

  3. HOMA-IR index

    Time frame: 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).

  4. plasma IL-34

    Time frame: Three months

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

  5. serum visfatin

    Time frame: Three Months

    serum visfatin concentrations enzyme- immunoassay kit

  6. IRAPe

    Time frame: Three months

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

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2019
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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