High Sensitive CRP in Prediabetics and Diabetes

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

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

Study Overview

• Status: Completed
• Conditions: Assess Level of High Sensitive CRP in Diabetics and Prediabetics

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

• Study Type: Observational
• Enrollment (Actual): 180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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%

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 10, 2018
• Study Completion (Actual): March 8, 2018

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypersensitivity; Prediabetic State
• Other Study ID Numbers: D84

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: still to be decided later

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No