Clinical trial NCT04971252: Type 2 Diabetes Mellitus and Chronic Kidney Disease
Official title: Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Non-dialysis Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Disorder Associated With Type II Diabetes Mellitus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will classify study population into 3 groups First group those population with only type 2 diabetes mellitus Second group is those population with chronic kidney disease only Third group is those population with combined type 2 diabetes mellitus and chronic kidney disease

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin concentration
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by INR
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by partial thromboplastin time
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by serum fibrinogen
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by mean platelet volume
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width
timeFrame: 1 day
measure: Estimate risk of thrombosis or bleeding for the 3 study groups by plateletcrit
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
citation: Gundogan K, Bayram F, Capak M, Tanriverdi F, Karaman A, Ozturk A, Altunbas H, Gokce 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.
citation: 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.
citation: 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.