Renal Disorder Associated With Type II Diabetes MellitusNCT04971252
Type 2 Diabetes Mellitus and Chronic Kidney Disease
An observational study of Renal Disorder Associated With Type II Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Disorder Associated With Type II Diabetes Mellitus
- What is being tested?
- Hematologic tests for patients with diabetes mellitus and chronic kidney disease
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2021to 7 Jul 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with diabetes mellitus with and without chronic kidney disease Patients with chronic kidney disease without diabetes mellitus
Who cannot join
- any situation influence on basic coagulation profile and platelet indices other than diabetes mellitus and chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Non-dialysis Chronic Kidney Disease Patients
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
- Being tested
- Hematologic tests for patients with diabetes mellitus and chronic kidney disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematologic tests for patients with diabetes mellitus and chronic kidney diseaseDiagnostic test
Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
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
Measured: 1 day
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 )
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start7 Jul 2021
- Primary completion23 Mar 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Disorder Associated With Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalaf Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971252
- Sponsor's protocol ID
- Soh-Med-21-07-24
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 19754305Odegaard 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 27013319Ulutas 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Type II Diabetes Mellitus on Basic Coagulation Profile and Platelet Indices in Non-dialysis Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT04971252
- Acronym / sponsor ID
- Soh-Med-21-07-24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co existance of diabetes mellitus and chronic kidney disease | – | Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among those patients with combined diabetes mellitus and chronic kidney disease |
| Diabetes mellitus without chronic kidney disease | – | Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among those patients with diabetes mellitus only |
| Chronic kidney disease without diabetes mellitus | – | Diagnostic Test: Hematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among those patients with chronic kidney disease without diabetes mellitus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with diabetes mellitus with and without chronic kidney disease Patients with chronic kidney disease without diabetes mellitus
Key exclusion criteria (1 listed)
- any situation influence on basic coagulation profile and platelet indices other than diabetes mellitus and chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematologic tests for patients with diabetes mellitus and chronic kidney diseaseStudy basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease | Diagnostic test | Chronic kidney disease without diabetes mellitus, Co existance of diabetes mellitus and chronic kidney disease, Diabetes mellitus without chronic kidney disease |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 19754305Gundogan 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.
- Background: PubMed 27013319Odegaard 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.
- Background: PubMed 24955167Ulutas 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disorder Associated With Type II Diabetes Mellitus, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate risk of thrombosis or bleeding for the 3 study groups by prothrombin time (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.