NCT05215821

Brief Summary

this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic \& Non Obese Patients.

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
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

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

Study Start

First participant enrolled

February 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

January 18, 2022

Last Update Submit

January 18, 2022

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • HOMA IR level estimated by Two-site immunoenzymometric assay

    4 months

Study Arms (2)

group1

subjects with evidence of insulin resistance estimated by high HOMA level

group 2

subjects without insulin resistance estimated by normal HOMA level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing coronary angiography due to suspected coronary artery disease

You may qualify if:

  • patients undergoing coronary angiography (CA) for ACS or stable angina in the Catheterization Laboratory of internal Medicine department and El Noor specialized cardiac center at the study period.

You may not qualify if:

  • age \< 18 years,
  • pregnancy or breastfeeding,
  • BMI \>30 Kg/m2 and
  • presence of pre-diabetes or overt diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag uniersity hosoital

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ali mo Altaher, lecturer

    Sohag faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali mo Altaher, lecturer

CONTACT

01003376529dr.ali.altaher30@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

February 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 28, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

EG(1)