NCT05719740

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 31, 2023

Last Update Submit

January 31, 2023

Conditions

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

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

    1 year

Study Arms (2)

45 patients in type 1 .DM

TYPE 1 DIABETES MELLITUS

Diagnostic Test: osteocrin

and 45 patients in type 2DM

TYPE 2 DIABETES MELLITUS

Diagnostic Test: osteocrin

Interventions

osteocrinDIAGNOSTIC_TEST

laboratory routine test

Also known as: laboratory routine test
45 patients in type 1 .DMand 45 patients in type 2DM

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

walaa soliman Hussien

Asyut, Egypt

RECRUITING

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2025

Last Updated

February 9, 2023

Record last verified: 2023-01

Locations

EG(1)