Type 2 Diabetes Mellitus and Chronic Kidney Disease

Overview

To investigate the effect of co existance of diabetes mellitus and chronic kidney disease on basic coagulation profile in comparison with diabetic patients with normal kidney function and non diabetic patients with chronic kidney disease

Full Title of Study: “Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Patients With Chronic Kidney Disease”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2023

Detailed Description

We will study impact of type 2 diabetes mellitus on basic coagulation profile and platelet indices among patients with chronic kidney disease

Interventions

  • Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease
    • Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease

Arms, Groups and Cohorts

  • Co existance of diabetes mellitus and chronic kidney disease
    • Study basic coagulation profile and platelet indices among those patients with combined diabetes mellitus and chronic kidney disease
  • Diabetes mellitus without chronic kidney disease
    • Study basic coagulation profile and platelet indices among those patients with diabetes mellitus only
  • Chronic kidney disease without diabetes mellitus
    • Study basic coagulation profile and platelet indices among those patients with chronic kidney disease without diabetes mellitus

Clinical Trial Outcome Measures

Primary Measures

  • Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time
    • Time Frame: 1 day
    • We will include 150 patients and classify them into 3 groups each one consists of 50 patients First group those patients with diabetes mellitus only Second group those patients with chronic kidney disease only Third group those patients with combined diabetes mellitus type 2 and chronic kidney disease not on hemodialysis First we will measure prothrombin time
  • Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin concentration
    • Time Frame: 1 day
    • We will include 150 patients classified into 3 groups as previous Second measure is prothrombin concentration
  • Estimate risk of thrombosis or bleeding for the 3 study groups by INR
    • Time Frame: 1 day
    • We will include 150 patients as previous Third measure is INR ( international normalised ratio )
  • Estimate risk of thrombosis or bleeding for the 3 study groups by partial thromboplastin time
    • Time Frame: 1 day
    • We will include 150 patients as previous Fourth measure is partial thromboplastin time
  • Estimate risk of thrombosis or bleeding for the 3 study groups by serum fibrinogen
    • Time Frame: 1 day
    • We will include 150 patients as previous Fifth measure is serum fibrinogen level in the 3 groups
  • Estimate risk of thrombosis or bleeding for the 3 study groups by mean platelet volume
    • Time Frame: 1 day
    • We will include 150 patients as previous Sixth measure is mean platelet volume in the 3 groups
  • Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width
    • Time Frame: 1 day
    • We will include 150 patients as previous Seventh measure is platelet distribution width for the 3 groups
  • Estimate risk of thrombosis or bleeding for the 3 study groups by plateletcrit
    • Time Frame: 1 day
    • We will include 150 patients as previous Eighth measure is plateletcrit of the 3 study groups

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with diabetes mellitus with and without chronic kidney disease Patients with chronic kidney disease without diabetes mellitus Exclusion Criteria:

  • any situation influence on basic coagulation profile and platelet indices other than diabetes mellitus and chronic kidney disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sohag University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed Khalaf Mohamed, Assistant lecturer – Sohag University
  • Overall Contact(s)
    • Mohamed K Mohamed, Assistant lecturer, 01007097994, Mohamed.khalaf@med.sohag.edu.eg

References

Gündogan K, Bayram F, Capak M, Tanriverdi F, Karaman A, Ozturk A, Altunbas H, Gökce C, Kalkan A, Yazici C. Prevalence of metabolic syndrome in the Mediterranean region of Turkey: evaluation of hypertension, diabetes mellitus, obesity, and dyslipidemia. Metab Syndr Relat Disord. 2009 Oct;7(5):427-34. doi: 10.1089/met.2008.0068.

Odegaard AO, Jacobs DR Jr, Sanchez OA, Goff DC Jr, Reiner AP, Gross MD. Oxidative stress, inflammation, endothelial dysfunction and incidence of type 2 diabetes. Cardiovasc Diabetol. 2016 Mar 24;15:51. doi: 10.1186/s12933-016-0369-6.

Ulutas KT, Dokuyucu R, Sefil F, Yengil E, Sumbul AT, Rizaoglu H, Ustun I, Yula E, Sabuncu T, Gokce C. Evaluation of mean platelet volume in patients with type 2 diabetes mellitus and blood glucose regulation: a marker for atherosclerosis? Int J Clin Exp Med. 2014 Apr 15;7(4):955-61. eCollection 2014.

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