High Sensitive CRP in Prediabetics and Diabetes

Assess Level of High Sensitive CRP in Diabetics and Prediabetics Clinical Trial

Official title:

High Sensitive CRP Level in Prediabetics and Newly Diagnosed Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673904
• Other study ID #: D84
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: September 2018
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 8, 2018
• Est. primary completion date: February 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Assess Level of High Sensitive CRP in Diabetics and Prediabetics
• Hypersensitivity
• Prediabetic State

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	statistical significant elevation of high sensitive CRP in diabetics and prediabetes		2 years