Diabetic NephropathiesNCT03284996
Doppler Ultrasound in Early Detection of Diabetic Nephropathy Type 2 Diabetes Mellitus.
An observational study of Diabetic Nephropathies, run by Assiut University.
Trial summary
Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Doppler ultrasonography
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Sep 2019
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was designed as a single-center case control study in which we'll evaluate intra-renal hemodynamic changes with Doppler sonography in diabetic patients in comparison to non-diabetic controls, by studying 80 cases, 40 cases of patients with type 2 diabetes mellitus from the diabetes \& nephrology outpatient clinic in Assiut University Hospital (group A) and 40 age-matched healthy adults served as a control group (group B).
Who may be able to join
- 1. Type 2 diabetic patients. 2. Serum creatinine <1.2 mg/dl
Who cannot join
- 1. patients with known history of renal disease or any systemic diseases with renal complications.
- 2. Serum creatinine >1.2 mg/dl
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Doppler Ultrasound in Early Detection of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus.
Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index.
Read the detailed description
Nephropathy is one of the most common long-term, life-threatening complications causing a high rate of morbidity and mortality among individual patients with type 2 diabetes.
The onset and progression of nephropathy can be delayed by interventions, provided they are instituted early in the course of the disease.
Doppler sonography allows non-invasive method for investigating renal hemodynamics. Renal resistive index measured using Doppler ultrasonography, reflects intra-renal vascular resistance.
Although Doppler sonography clearly does not substitute for renal biopsy, several studies have suggested that it might aid in the management of established renal disease and provide an easily applicable and noninvasive method for investigating renal hemodynamics.
Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index. It is one of the most sensitive parameters in the study of kidney diseases and allows us to quantify the changes in renal plasma flow . A normal resistive index is below 0.7 in adults and children who are six years of age or older.
- Conditions
- Diabetic Nephropathies
- Being tested
- Doppler ultrasonography
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonographyDevice
Examination of the whole cases \& controls by doppler ultrasound to measure renal resistive index.
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shery Dawood Yassa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284996
- Sponsor's protocol ID
- DUDN
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.
PubMed 2970215Tublin ME, Bude RO, Platt JF. Review. The resistive index in renal Doppler sonography: where do we stand? AJR Am J Roentgenol. 2003 Apr;180(4):885-92. doi: 10.2214/ajr.180.4.1800885. No abstract available.
PubMed 12646425Tang SC, Chan GC, Lai KN. Recent advances in managing and understanding diabetic nephropathy. F1000Res. 2016 May 31;5:F1000 Faculty Rev-1044. doi: 10.12688/f1000research.7693.1. eCollection 2016.
PubMed 27303648Mancini M, Masulli M, Liuzzi R, Mainenti PP, Ragucci M, Maurea S, Riccardi G, Vaccaro O. Renal duplex sonographic evaluation of type 2 diabetic patients. J Ultrasound Med. 2013 Jun;32(6):1033-40. doi: 10.7863/ultra.32.6.1033.
PubMed 23716525
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Doppler Ultrasound in Early Detection of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT03284996
- Acronym / sponsor ID
- DUDN
- Conditions
- Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 15 Sep 2017 (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.
Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index.
Detailed description
Nephropathy is one of the most common long-term, life-threatening complications causing a high rate of morbidity and mortality among individual patients with type 2 diabetes.
The onset and progression of nephropathy can be delayed by interventions, provided they are instituted early in the course of the disease.
Doppler sonography allows non-invasive method for investigating renal hemodynamics. Renal resistive index measured using Doppler ultrasonography, reflects intra-renal vascular resistance.
Although Doppler sonography clearly does not substitute for renal biopsy, several studies have suggested that it might aid in the management of established renal disease and provide an easily applicable and noninvasive method for investigating renal hemodynamics.
Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index. It is one of the most sensitive parameters in the study of kidney diseases and allows us to quantify the changes in renal plasma flow . A normal resistive index is below 0.7 in adults and children who are six years of age or older.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was designed as a single-center case control study in which we'll evaluate intra-renal hemodynamic changes with Doppler sonography in diabetic patients in comparison to non-diabetic controls, by studying 80 cases, 40 cases of patients with type 2 diabetes mellitus from the diabetes \& nephrology outpatient clinic in Assiut University Hospital (group A) and 40 age-matched healthy adults served as a control group (group B).
Key inclusion criteria (1 listed)
- 1. Type 2 diabetic patients. 2. Serum creatinine <1.2 mg/dl
Key exclusion criteria (2 listed)
- 1. patients with known history of renal disease or any systemic diseases with renal complications.
- 2. Serum creatinine >1.2 mg/dl
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 |
|---|---|---|
| Doppler ultrasonographyExamination of the whole cases \& controls by doppler ultrasound to measure renal resistive index. | Device | – |
Primary outcome
Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
Time frame: 2 years
Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Results publication: PubMed 2970215Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.
- Results publication: PubMed 12646425Tublin ME, Bude RO, Platt JF. Review. The resistive index in renal Doppler sonography: where do we stand? AJR Am J Roentgenol. 2003 Apr;180(4):885-92. doi: 10.2214/ajr.180.4.1800885. No abstract available.
- Results publication: PubMed 27303648Tang SC, Chan GC, Lai KN. Recent advances in managing and understanding diabetic nephropathy. F1000Res. 2016 May 31;5:F1000 Faculty Rev-1044. doi: 10.12688/f1000research.7693.1. eCollection 2016.
- Results publication: PubMed 23716525Mancini M, Masulli M, Liuzzi R, Mainenti PP, Ragucci M, Maurea S, Riccardi G, Vaccaro O. Renal duplex sonographic evaluation of type 2 diabetic patients. J Ultrasound Med. 2013 Jun;32(6):1033-40. doi: 10.7863/ultra.32.6.1033.
Related trials for Diabetic Nephropathies
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, 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 1 inclusion and 2 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 15 Sep 2017. 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 Hassan Ibrahim Megally, Professor (00201006209845, hasanibrahim48@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography (time frame: 2 years). 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 NCT03284996, which also lists 4 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 15 Sep 2017.