Clinical trial NCT05719740: Osteocrin and Vascular Complications
Official title: Osteocrin ,a Novel Predictive Bone-derived Humoral Factor,in Diabetes Mellitus, and Its Relation With Glycemic Control and Vascular Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Whether Osteocrin Levels Are Associated With Glycemic Control, Vascular Disorders in Diabetic Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: to test and evaluate the role of bone-derived factor (osteocrin) in glucose metabolism,in diabetic patients with risk of micro and macrovascular complications .
timeFrame: 2 years
Secondary outcomes:
measure: to identify bone-derived factor (osteocrin) may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: walaa soliman Hussien
Study officials:
References: