Kidney Function Affection Upon Exposure to RadiocontrastVCG4NCT03470454
Contrast Nephropathy in Type 2 Diabetes
An observational study of Kidney Function Affection Upon Exposure to Radiocontrast and Diabetes, run by Fayoum University at 2 sites in Egypt.
Trial summary
To study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Kidney Function Affection Upon Exposure to Radiocontrast, Diabetes, Microalbuminuria
- What is being tested?
- Linagliptin Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2018to 30 Nov 2018
- How long will I take part?
- 1 Week
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum university hospital will be selected.
Who may be able to join
- Diabetics on DPP 4 inhibitor treatment
Who cannot join
- Diabetics on insulin
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine Fayoum univesity
Al Fayyum
Fayoum University
Al Fayyum
About this study
Official title: Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria
To study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria
Read the detailed description
Study design:
This study will be an observational prospective cohort study.
Study population:
Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors.
Data collection:
Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.
- Being tested
- Linagliptin Oral Tablet
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin Oral TabletDrug
Linagliptin for blood glucose control
| Study group | Role | What they receive |
|---|---|---|
| diabetics on linagelptin | Diabetic patients were given linagelptin for blood glucose control Receives: Drug: Linagliptin Oral Tablet | |
| diabetics on other DPP4 inhibitors | Diabetic pateints were given other DPP4 inhibitors eg: vlidagliptin for blood glucose control Receives: Drug: Linagliptin Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
affection of estimated glomerular filtration rate
A significant decrease in estimated glomerular filtration rate (eGFR)
Measured: Two months
Secondary outcomes (1)
change in serum uric acid
A significant rise in serum uric acid
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jul 2018
- Primary completion30 Sep 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Function Affection Upon Exposure to RadiocontrastStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Ahmed Abdelkawi Hammad, Fayoum University
- Investigators
- Usama A Sharafeldin, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470454
- Sponsor's protocol ID
- VCG 4
- Acronym
- VCG4
- Status last verified
- Sep 2020
- First submitted
- 9 Mar 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fayed A, Hammad AA, Abdulazim DO, Hammad H, Amin M, Elhadidy S, Salem MM, ElAzim IMA, Zsom L, Csongradi E, Soliman KM, Sharaf El Din UA. Is the combination of linagliptin and allopurinol better prophylaxis against post-contrast acute kidney injury? A multicenter prospective randomized controlled study. Ren Fail. 2023 Dec;45(1):2194434. doi: 10.1080/0886022X.2023.2194434.
PubMed 36974638
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria
- ClinicalTrials.gov ID
- NCT03470454
- Acronym / sponsor ID
- VCG4 / VCG 4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 20 Mar 2018 (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 study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria
Detailed description
Study design:
This study will be an observational prospective cohort study.
Study population:
Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors.
Data collection:
Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetics on linagelptin | – | Drug: Linagliptin Oral TabletDiabetic patients were given linagelptin for blood glucose control |
| diabetics on other DPP4 inhibitors | – | Drug: Linagliptin Oral TabletDiabetic pateints were given other DPP4 inhibitors eg: vlidagliptin for blood glucose control |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum university hospital will be selected.
Key inclusion criteria (1 listed)
- Diabetics on DPP 4 inhibitor treatment
Key exclusion criteria (1 listed)
- Diabetics on insulin
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 |
|---|---|---|
| Linagliptin Oral TabletLinagliptin for blood glucose control | Drug | diabetics on linagelptin, diabetics on other DPP4 inhibitors |
Primary outcome
affection of estimated glomerular filtration rate
Time frame: Two months
A significant decrease in estimated glomerular filtration rate (eGFR)
1 secondary outcome
change in serum uric acid
Time frame: Two months
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 16 Sep 2020.
- Derived from this study: PubMed 36974638Fayed A, Hammad AA, Abdulazim DO, Hammad H, Amin M, Elhadidy S, Salem MM, ElAzim IMA, Zsom L, Csongradi E, Soliman KM, Sharaf El Din UA. Is the combination of linagliptin and allopurinol better prophylaxis against post-contrast acute kidney injury? A multicenter prospective randomized controlled study. Ren Fail. 2023 Dec;45(1):2194434. doi: 10.1080/0886022X.2023.2194434.
- Individual participant dataSharing planned: Undecided
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.
Usama A Sharafeldin, MD study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Function Affection Upon Exposure to Radiocontrast and Diabetes, run by Fayoum University at 2 sites 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
affection of estimated glomerular filtration rate (time frame: Two months). 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 NCT03470454, which also lists 1 linked publication.
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 16 Sep 2020.