Frequency Of Eye Problems In Type 2 Diabetes With Chronic Kidney Disease

November 4, 2017 updated by: Mohammed Ramadan Abdallah
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 :

  1. A detailed history including

    1. Age, sex, smoking Habits
    2. Duration of diabetes mellitus and treatment.
    3. Chronic kidney disease stage by estimated glomerular filtration rate according to MDRD formula
    4. Duration of haemodialysis.
    5. Associated co-morbidity as hypertension,
    6. Therapeutic history eg; angiotensin converting enzyme, angiotensin II receptor blocker, amiodarone, erythropoietin.
  2. Complete Clinical examination including haemodynamics, complete cardiac, chest, abdominal, lower limb examination, cranial nerve examination.

  3. 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.

  4. 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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with previous history of eye problems and any systemic disease.
  • Type 1 Diabetics .
  • Acute kidney injury in Diabetics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
50 patients Type 2 Diabetes without renal impairment will be examined using fundoscope
Device: fundoscope
Fundoscope for eye examination
Group B
25 patients Type 2 Diabetes with chronic kidney disease not on replacement therapy (stage I-IV) will be examined using fundoscope
Device: fundoscope
Fundoscope for eye examination
Group C
25 patients Type 2 Diabetes with end stage renal disease on haemodialysis will be examined using fundoscope
Device: fundoscope
Fundoscope for eye examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days for each participant to be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed Ramadan Abdallah

Collaborators

Assiut University

Investigators

  • Study Chair: Lobna F El-Toony, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 4, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU MRAbdallah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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