Eye DiseasesNCT03330054
Frequency Of Eye Problems In Type 2 Diabetes With Chronic Kidney Disease
An observational study of Eye Diseases and Renal Impairment, run by Mohammed Ramadan Abdallah.
Trial summary
This study evaluate the frequency and type of eye problem among Type 2 Diabetics with renal impairment and effect of renal impairment and haemodialysis on diabetic retinopathy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Diseases, Renal Impairment, Type2 Diabetes
- What is being tested?
- fundoscope
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Jun 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group A 50 patients Type 2 Diabetes without renal impairment. from outpatient clinic Group B 25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy. (stage I-IV) from outpatient clinic and admitted patient in Luxor International Hospital. Group C 25 patients Type 2 Diabetes with end-stage renal disease on haemodialysis from Haemodialysis unit in Luxor International Hospital.
Who may be able to join
- 50 patients Type 2 Diabetes without renal impairment.
- 25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy. (stage I-IV)
- 25 patients Type 2 Diabetes with end-stage renal disease on haemodialysis
Who cannot join
- patients with previous history of eye problems and any systemic disease.
- Type 1 Diabetics .
- Acute kidney injury in Diabetics.
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluate the frequency and type of eye problem among Type 2 Diabetics with renal impairment and effect of renal impairment and haemodialysis on diabetic retinopathy
Read the detailed description
Chronic kidney disease is a descriptive term and is used for deteriorating kidney function of any underlying cause. Chronic kidney disease implies longstanding (>3 months), potentially progressive, impairment in renal function.(Kumar \& Clark's ., 2016).
Diabetes mellitus is the most common cause of chronic kidney disease in developed countries. In patients with diabetes, there is a steady advance from microalbuminuria to dipstick positive proteinuria and a progression to renal failure. (Davidson's.,2014) .The most commonly diagnosed diabetes-related complications is diabetic retinopathy. Its prevalence increases with the duration of diabetes. Some 20%of people with type 1 diabetes will have retinal changes after 10 years, rising to >95% after20 years; 20-30% of people with type 2 diabetes have retinopathy at diagnosis.(Kumar \& Clark's ., 2016) .
Also from risk factors of diabetic retinopathy is nephropathy, and if severe, is associated with worsening of Diabetic retinopathy. Conversely, treatment of renal disease (e.g. renal transplantation) may be associated with improvement of retinopathy and a better response to photocoagulation.(Kanaski ,2016) The high burden of ocular disease in Chronic kidney disease can be explained, in part, by the sharing of risk factors common to both kidney and eye diseases such as age, smoking, hypertension, diabetes, raised serum cholesterol and obesity. Ocular diseases may also be directly linked to chronic kidney disease via common pathogenic pathways, including, atherosclerosis, microangiopathy, inflammation and oxidative stress (Wong et al., 2014).
In our study we seek to do the following for participants :
- A detailed history including
- Age, sex, smoking Habits
- Duration of diabetes mellitus and treatment.
- Chronic kidney disease stage by estimated glomerular filtration rate according to MDRD formula
- Duration of haemodialysis.
- Associated co-morbidity as hypertension,
- Therapeutic history eg; angiotensin converting enzyme, angiotensin II receptor blocker, amiodarone, erythropoietin.
- Complete Clinical examination including haemodynamics, complete cardiac, chest, abdominal, lower limb examination, cranial nerve examination.
- Complete eye examination including detailed fundus examination, classifying expected eye problems as:
- Cataract. - Glaucoma
- Cranial nerve affection
- Retinopathy either proliferative, non proliferative or macular oedema.
- The following investigations will be done:
- Serum creatinine \& Blood Urea for estimation of glomerular filtration rate
- Glycated haemoglobin (HbA1c).
- lipogram.
- Complete blood count
- ECG
- Conditions
- Eye Diseases, Renal Impairment, Type2 Diabetes
- Being tested
- fundoscope
- Medical subject headings
- Eye Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fundoscopeDevice
Fundoscope for eye examination
| Study group | Role | What they receive |
|---|---|---|
| Group A | 50 patients Type 2 Diabetes without renal impairment will be examined using fundoscope Receives: Device: fundoscope | |
| Group B | 25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy (stage I-IV) will be examined using fundoscope Receives: Device: fundoscope | |
| Group C | 25 patients Type 2 Diabetes with end stage renal disease on haemodialysis will be examined using fundoscope Receives: Device: fundoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency Of Eye problems In Type 2 Diabetes with Chronic Kidney Disease
To evaluate the frequency and type of eye problem among:
- Type 2 Diabetics not having renal impairment.
- Type 2 Diabetics with chronic kidney disease not on replacement therapy.
- Type 2 Diabetics with end stage renal disease on haemodialysis.
Measured: 2 days for each participant to be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Ramadan Abdallah
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Mohammed Ramadan Abdallah, Assiut University
- Investigators
- Lobna F El-Toony, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330054
- Sponsor's protocol ID
- AssiutU MRAbdallah
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Of Eye Problems In Type 2 Diabetes With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03330054
- Acronym / sponsor ID
- AssiutU MRAbdallah
- Conditions
- Eye Diseases, Renal Impairment, Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mohammed Ramadan AbdallahUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 6 Nov 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.
This study evaluate the frequency and type of eye problem among Type 2 Diabetics with renal impairment and effect of renal impairment and haemodialysis on diabetic retinopathy
Detailed description
Chronic kidney disease is a descriptive term and is used for deteriorating kidney function of any underlying cause. Chronic kidney disease implies longstanding (>3 months), potentially progressive, impairment in renal function.(Kumar \& Clark's ., 2016).
Diabetes mellitus is the most common cause of chronic kidney disease in developed countries. In patients with diabetes, there is a steady advance from microalbuminuria to dipstick positive proteinuria and a progression to renal failure. (Davidson's.,2014) .The most commonly diagnosed diabetes-related complications is diabetic retinopathy. Its prevalence increases with the duration of diabetes. Some 20%of people with type 1 diabetes will have retinal changes after 10 years, rising to >95% after20 years; 20-30% of people with type 2 diabetes have retinopathy at diagnosis.(Kumar \& Clark's ., 2016) .
Also from risk factors of diabetic retinopathy is nephropathy, and if severe, is associated with worsening of Diabetic retinopathy. Conversely, treatment of renal disease (e.g. renal transplantation) may be associated with improvement of retinopathy and a better response to photocoagulation.(Kanaski ,2016) The high burden of ocular disease in Chronic kidney disease can be explained, in part, by the sharing of risk factors common to both kidney and eye diseases such as age, smoking, hypertension, diabetes, raised serum cholesterol and obesity. Ocular diseases may also be directly linked to chronic kidney disease via common pathogenic pathways, including, atherosclerosis, microangiopathy, inflammation and oxidative stress (Wong et al., 2014).
In our study we seek to do the following for participants :
- A detailed history including
- Age, sex, smoking Habits
- Duration of diabetes mellitus and treatment.
- Chronic kidney disease stage by estimated glomerular filtration rate according to MDRD formula
- Duration of haemodialysis.
- Associated co-morbidity as hypertension,
- Therapeutic history eg; angiotensin converting enzyme, angiotensin II receptor blocker, amiodarone, erythropoietin.
- Complete Clinical examination including haemodynamics, complete cardiac, chest, abdominal, lower limb examination, cranial nerve examination.
- Complete eye examination including detailed fundus examination, classifying expected eye problems as:
- Cataract. - Glaucoma
- Cranial nerve affection
- Retinopathy either proliferative, non proliferative or macular oedema.
- The following investigations will be done:
- Serum creatinine \& Blood Urea for estimation of glomerular filtration rate
- Glycated haemoglobin (HbA1c).
- lipogram.
- Complete blood count
- ECG
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: fundoscope50 patients Type 2 Diabetes without renal impairment will be examined using fundoscope |
| Group B | – | Device: fundoscope25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy (stage I-IV) will be examined using fundoscope |
| Group C | – | Device: fundoscope25 patients Type 2 Diabetes with end stage renal disease on haemodialysis will be examined using fundoscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group A 50 patients Type 2 Diabetes without renal impairment. from outpatient clinic Group B 25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy. (stage I-IV) from outpatient clinic and admitted patient in Luxor International Hospital. Group C 25 patients Type 2 Diabetes with end-stage renal disease on haemodialysis from Haemodialysis unit in Luxor International Hospital.
Key inclusion criteria (3 listed)
- 50 patients Type 2 Diabetes without renal impairment.
- 25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy. (stage I-IV)
- 25 patients Type 2 Diabetes with end-stage renal disease on haemodialysis
Key exclusion criteria (3 listed)
- patients with previous history of eye problems and any systemic disease.
- Type 1 Diabetics .
- Acute kidney injury in Diabetics.
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 |
|---|---|---|
| fundoscopeFundoscope for eye examination | Device | Group A, Group B, Group C |
Primary outcome
Frequency Of Eye problems In Type 2 Diabetes with Chronic Kidney Disease
Time frame: 2 days for each participant to be assessed
To evaluate the frequency and type of eye problem among: 1. Type 2 Diabetics not having renal impairment. 2. Type 2 Diabetics with chronic kidney disease not on replacement therapy. 3. Type 2 Diabetics with end stage renal disease on haemodialysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Lobna F El-Toony, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases and Renal Impairment, run by Mohammed Ramadan Abdallah.
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 3 inclusion and 3 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 7 Nov 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 Mohamed R Abdallah (00201011770935 ext. 0020952600399, drmramadanas33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency Of Eye problems In Type 2 Diabetes with Chronic Kidney Disease (time frame: 2 days for each participant to be assessed). 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 7 Nov 2017.