Insulin Resistance and Severity of Coronary Artery Disease | NCT05215821

Studies
Insulin Resistance and Severity of Coronary Artery Disease

NCT05215821

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 31, 2022Actual

Enrollment

112Estimated

Phase

Not provided

Conditions

Insulin Resistance

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Jan 30, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Jan 18, 2022

First Submission Date that Met QC Criteria

Jan 18, 2022

First Posted Date

Jan 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2022

Last Update Posted Date

Jan 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group1		subjects with evidence of insulin resistance estimated by high HOMA level
group 2		subjects without insulin resistance estimated by normal HOMA level

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HOMA IR level estimated by Two-site immunoenzymometric assay		4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing coronary angiography due to suspected coronary artery disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali mo Altaher, lecturer	Contact	01003376529	+20	dr.ali.altaher30@gmail.com

Overall Officials

Name	Affiliation	Role
Ali mo Altaher, lecturer	Sohag faculty of medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag uniersity hosoital	Recruiting	Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided