Renal Disorder Associated With Type II Diabetes Mellitus Clinical Trial
Official title:
Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Non-dialysis Chronic Kidney Disease Patients
| NCT number | NCT04971252 |
| Other study ID # | Soh-Med-21-07-24 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 7, 2021 |
| Est. completion date | July 7, 2023 |
| Verified date | January 2024 |
| Source | Sohag University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | July 7, 2023 |
| Est. primary completion date | March 23, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Sohag University | Sohag |
| Lead Sponsor | Collaborator |
|---|---|
| Sohag University |
Egypt,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time | 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 | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin concentration | We will include 150 patients classified into 3 groups as previous Second measure is prothrombin concentration | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by INR | We will include 150 patients as previous Third measure is INR ( international normalised ratio ) | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by partial thromboplastin time | We will include 150 patients as previous Fourth measure is partial thromboplastin time | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by serum fibrinogen | We will include 150 patients as previous Fifth measure is serum fibrinogen level in the 3 groups | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by mean platelet volume | We will include 150 patients as previous Sixth measure is mean platelet volume in the 3 groups | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by platelet distribution width | We will include 150 patients as previous Seventh measure is platelet distribution width for the 3 groups | 1 day | |
| Primary | Estimate risk of thrombosis or bleeding for the 3 study groups by plateletcrit | We will include 150 patients as previous Eighth measure is plateletcrit of the 3 study groups | 1 day |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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