High Sensitive CRP in Prediabetics and Diabetes | NCT03673904

Studies
High Sensitive CRP in Prediabetics and Diabetes

NCT03673904

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Sep 17, 2018Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Assess Level of High Sensitive CRP in Diabetics and Prediabetics

Interventions

Not provided

Countries

Not provided

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Feb 10, 2018Actual

Completion Date

Mar 8, 2018Actual

First Submitted Date

Sep 14, 2018

First Submission Date that Met QC Criteria

Sep 14, 2018

First Posted Date

Sep 17, 2018Actual

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

Sep 14, 2018

Last Update Posted Date

Sep 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c

Detailed Description

This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. The study individuals will be recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prediabetics		Ages ranging from 18 to 60 years old,males and females were included . A fasting blood glucose level (100 to 125 mg/dL). or A 2-hour blood glucose level (140 to 199 mg/dL) .or Hb A1C 5.7% to 6.4%.
Newly diagnosed type 2 diabetes		Ages ranging from 18 to 60 years old,males and females were included Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis) A fasting blood glucose level >126 mg/dl A 2-hour blood glucose level > 200 mg/d Hb A1C > 6.5%

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
statistical significant elevation of high sensitive CRP in diabetics and prediabetes		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pre-diabetic patients:
- A fasting blood glucose level (100 to 125 mg/dL). or
- A 2-hour blood glucose level (140 to 199 mg/dL) .or
- Hb A1C 5.7% to 6.4%.
Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis)
- A fasting blood glucose level >126 mg/dl
- A 2-hour blood glucose level > 200 mg/dl
- Hb A1C > 6.5%

Exclusion Criteria:

Pregnant or lactating females.
Patients who have recent infection.
Patients with acute inflammatory diseases as autoimmune diseases.
Patients with malignancy or on chemotherapy.
Patients with acute or chronic liver or renal diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

The study individuals were recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

still to be decided later

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided