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CompletedNCT04971252Updated Jan 9, 2024

Type 2 Diabetes Mellitus and Chronic Kidney Disease

An observational study in Renal Disorder Associated With Type II Diabetes Mellitus, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 150 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • Patients with diabetes mellitus with and without chronic kidney disease Patients with chronic kidney disease without diabetes mellitus

Exclusion criteria

Exclusion Criteria:

  • any situation influence on basic coagulation profile and platelet indices other than diabetes mellitus and chronic kidney disease
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
None retained

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

    Diagnostic Test: Hematologic tests for patients with 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

    Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease

  • Chronic kidney disease without diabetes mellitus

    Study basic coagulation profile and platelet indices among those patients with chronic kidney disease without diabetes mellitus

    Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease

Interventions

  • Diagnostic testHematologic tests for patients with diabetes mellitus and chronic kidney disease

    Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. 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 )

    Time frame: 1 day

  4. 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

    Time frame: 1 day

  5. 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

    Time frame: 1 day

  6. 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

    Time frame: 1 day

  7. 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

    Time frame: 1 day

  8. 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

    Time frame: 1 day

07

Study locations

1 site
  • Sohag University
    Sohag, Egypt
08

References and documents

Publications

  • 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. PubMed 19754305 ↗
  • 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. PubMed 27013319 ↗
  • 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. PubMed 24955167 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04971252
Lead sponsor
Sohag University
Responsible party
Mohamed Khalaf Mohamed (Assistant lecturer, Sohag University) — Principal investigator
First posted
Jul 21, 2021
Start date
Jul 7, 2021
Primary completion
Mar 23, 2023
Completion
Jul 7, 2023
Last update
Jan 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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