Type 2 DM /Diabetic NephropathyNCT05681286
CRP to Serum Albumin Ratio in Type 2 DM é Diabetic Nephropathy
An observational study of Type 2 DM /Diabetic Nephropathy, run by Assiut University.
Trial summary
we aimed to compare C-reactive protein to serum albumin ( CAR) level of the T2DM patients with DN to those T2DM without DN Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 DM /Diabetic Nephropathy
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2023to 4 Aug 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: type 2 DM patients
Who may be able to join
None listed.
Who cannot join
- Type 1 diabetes is , patient t with liver cirrhosis, patient with active infection ,pregnant women,patients with cancer
Trial locations and contacts
No sites are listed yet.
About this study
Official title: C-reactive Protein to Serum Albumin Ratio in Type 2diabetic Patients With Diabetic Nephropathy
we aimed to compare C-reactive protein to serum albumin ( CAR) level of the T2DM patients with DN to those T2DM without DN
Read the detailed description
Diabetic Nephropathy (DN) is a serious complication of Diabetes Mellitus associated with chronic and low-grade inflammatory burden affects around 30 % of diabetic patients It is the leading cause of end-stage renal failure worldwide and associated with cardio vascular diseases and increases mortality of diabetic patients It characterized by persistent albuminuria, raise in arterial blood pressure ,decrease in glomerular filtration rate (GFR) It associated with chronic low grade inflammation that's leads to increase glucose and activities inflammation Despite of the pathogenesis of DN is multifactorial, but local inflammatory process may result from both the metabolic and hemodynamic affection seen in DN sustained diabetes-related metabolic and haemodynamic perturbations can induce subclinical low-grade renal inflammation and drive kidney from repair response to damage process, eventually to renal fibrosis Chronic inflammatory processes not only play a principle role in the progression of micro vascular but also macro vascular complications in type 2 diabetes mellitus. An association between low -grade inflammation and type 2 diabetes has been described in recent studies .C- reactive protein to serum albumin ratio has attracted great attention recently , and used as biomarker in detection disease severity
, since type 2 Diabetes Mellitus and Diabetic Nephropathy(DN) is associated with low grade inflammation in recent studies. In this study investigator presume that C-reactive protein to serum albumin ratio ( CAR )levels could be associated with the progression of DN in patients with T2DM.
- Conditions
- Type 2 DM /Diabetic Nephropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein to serum albumin ratio in type 2diabetic patients with diabetic nephropathy
comparison between CAR level è type 2 diabetic nephropathy patient and those without nephropathy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start4 Aug 2023 (estimated)
- Primary completion4 Aug 2024 (estimated)
- Study completion4 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DM /Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa shahhat Abodahab, Assiut University
- Investigators
- Salah Argoon, Study chair, Assuit uAlshaimaa sayed, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681286
- Sponsor's protocol ID
- CAR level in type 2 DM
- Status last verified
- Dec 2022
- First submitted
- 25 Dec 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-reactive Protein to Serum Albumin Ratio in Type 2diabetic Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT05681286
- Acronym / sponsor ID
- CAR level in type 2 DM
- Conditions
- Type 2 DM /Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Aug 2023 (estimated)
- Primary completion
- 4 Aug 2024 (estimated)
- Study completion
- 4 Aug 2025 (estimated)
- First posted
- 12 Jan 2023 (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.
we aimed to compare C-reactive protein to serum albumin ( CAR) level of the T2DM patients with DN to those T2DM without DN
Detailed description
Diabetic Nephropathy (DN) is a serious complication of Diabetes Mellitus associated with chronic and low-grade inflammatory burden affects around 30 % of diabetic patients It is the leading cause of end-stage renal failure worldwide and associated with cardio vascular diseases and increases mortality of diabetic patients It characterized by persistent albuminuria, raise in arterial blood pressure ,decrease in glomerular filtration rate (GFR) It associated with chronic low grade inflammation that's leads to increase glucose and activities inflammation Despite of the pathogenesis of DN is multifactorial, but local inflammatory process may result from both the metabolic and hemodynamic affection seen in DN sustained diabetes-related metabolic and haemodynamic perturbations can induce subclinical low-grade renal inflammation and drive kidney from repair response to damage process, eventually to renal fibrosis Chronic inflammatory processes not only play a principle role in the progression of micro vascular but also macro vascular complications in type 2 diabetes mellitus. An association between low -grade inflammation and type 2 diabetes has been described in recent studies .C- reactive protein to serum albumin ratio has attracted great attention recently , and used as biomarker in detection disease severity
, since type 2 Diabetes Mellitus and Diabetic Nephropathy(DN) is associated with low grade inflammation in recent studies. In this study investigator presume that C-reactive protein to serum albumin ratio ( CAR )levels could be associated with the progression of DN in patients with T2DM.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- type 2 DM patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Type 1 diabetes is , patient t with liver cirrhosis, patient with active infection ,pregnant women,patients with cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
C-reactive protein to serum albumin ratio in type 2diabetic patients with diabetic nephropathy
Time frame: Baseline
comparison between CAR level è type 2 diabetic nephropathy patient and those without nephropathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Related trials for Type 2 DM /Diabetic Nephropathy
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
Enrolling by invitationPhase 4
Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
Type 2 DM, Type 2 DM /Diabetic Nephropathy
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.
Salah Argoon study chair
Assuit u
Alshaimaa sayed study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 DM /Diabetic Nephropathy, run by Assiut University.
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 0 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shymaa Shahhat, Master (01024302315, shoshahhat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein to serum albumin ratio in type 2diabetic patients with diabetic nephropathy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2023.