Osteocrin and Vascular Complications

NCT ID: NCT05719740

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-02-28

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.

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.

Conditions

Whether Osteocrin Levels Are Associated With Glycemic Control, Vascular Disorders in Diabetic Patients

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

45 patients in type 1 .DM

TYPE 1 DIABETES MELLITUS

osteocrin

Intervention Type: DIAGNOSTIC_TEST

laboratory routine test

and 45 patients in type 2DM

TYPE 2 DIABETES MELLITUS

osteocrin

Intervention Type: DIAGNOSTIC_TEST

laboratory routine test

Interventions

osteocrin

laboratory routine test

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

laboratory routine test

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Soliman Hussein

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

walaa soliman Hussien

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

walaa S Hussien

Role: primary

walaasoliman813@gmail.com

01062637403

Other Identifiers

Nephrologist

Identifier Type: -

Identifier Source: org_study_id