Osteocrin and Vascular Complications (Osteocrin)

Osteocrin ,a Novel Predictive Bone-derived Humoral Factor,in Diabetes Mellitus, and Its Relation With Glycemic Control and Vascular Complications

In this study, we aimed to describe the role of bone-derived factor (osteocrin) in glucose metabolism, micro and macrovascular complications in diabetic patients. Thus, further investigations of the endocrine system through bone-derived hormones may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus.

Study Overview

• Status: Recruiting
• Conditions: Whether Osteocrin Levels Are Associated With Glycemic Control, Vascular Disorders in Diabetic Patients
• Intervention / Treatment: Diagnostic test: osteocrin

Detailed Description

Diabetes mellitus (DM) remained the most common metabolic disorder worldwide occupying the 8th leading cause of death.[1] Defining new predictive biomarkers in diabetes would provide a window of opportunity for preventive and/or therapeutic interventions to prevent or delay the onset of irreversible long-term micro and or macro vascular complications. Progressive micro vascular vaso-degeneration is the major factor in progression of diabetic complications and contribute greatly to the increased mortality and morbidity. [2] Where Hemodynamic-mediated vascular injury was considered as one mechanism in the pathogenesis of diabetic nephropathy. [3] Bone disorders have been drawing attention as a novel diabetic complication, and diabetes is associated with an increased risk of osteoporotic fracture [4-6]. Bone is considered as an endocrine organ that influences various organs and tissues via the secretion of multiple bone derived hormones [7-8]. These endocrinal functions are, for example, glucose homeostasis [9], appetite control [10], fat deposition [11], skeletal muscle adaptation [12], male fertility [13], and cognition [14].

Therefore, these bone-derived hormones can become useful biomarkers for predicting the incidence of diabetes and the progression of diabetic complications. Osteocrin (OSTN), a bone-derived humoral factor, is a small secreted peptide cloned from bone and muscle complementary DNA (cDNA) libraries [15]. Osteocrin (Ostn) is secreted protein produced by cells of the osteoblast lineage that shows a well conserved homology with members of the natriuretic peptide (NP) family with prohormone-like characteristics [17]. To date, the exact role of Ostn has not been elucidated.

In this study, we aimed to describe the role of bone-derived factor (osteocrin) in glucose metabolism, micro and macrovascular complications in diabetic patients. Thus, further investigations of the endocrine system through bone-derived hormones may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • walaa soliman Hussien
    • Contact: walaa S Hussien; Phone Number: 01062637403; Email: walaasoliman813@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the estimated minimum required sample size is 90 patients ( 45 patients in type 1 and 45 patients in type 2).

Description

Inclusion Criteria:

- Cases of the study will select randomly, based on inclusion criteria that included

• Patients were diagnosed with diabetes mellitus according to American Diabetes Association
• Age range 20-70 years
• No apparent vascular abnormalities and Acute complications

Exclusion Criteria:

• Patients are excluded for participation in the study if

  • Patients had past history of cardiovascular events (heart failure or history of coronary artery disease),
  • infections,
  • aacute diabetic complications,
  • diabetic patients on regular hemodialysis .
  • acute illness, malignancy, or pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
45 patients in type 1 .DM; TYPE 1 DIABETES MELLITUS	Diagnostic test: osteocrin; laboratory routine test; Other Names: laboratory routine test
and 45 patients in type 2DM; TYPE 2 DIABETES MELLITUS	Diagnostic test: osteocrin; laboratory routine test; Other Names: laboratory routine test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to test and evaluate the role of bone-derived factor (osteocrin) in glucose metabolism,in diabetic patients with risk of micro and macrovascular complications .	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
to identify bone-derived factor (osteocrin) may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): February 1, 2025

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: Nephrologist

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No