Osteocrin and Vascular Complications

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05719740
Collaborator
(none)
90
1
24
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Osteocrin ,a Novel Predictive Bone-derived Humoral Factor,in Diabetes Mellitus, and Its Relation With Glycemic Control and Vascular Complications
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. to identify bone-derived factor (osteocrin) may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 walaa soliman Hussien Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walaa Soliman Hussein, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05719740
    Other Study ID Numbers:
    • Nephrologist
    First Posted:
    Feb 9, 2023
    Last Update Posted:
    Feb 9, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2023