Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330054
Recruitment Status : Unknown
Verified November 2017 by Mohammed Ramadan Abdallah, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Mohammed Ramadan Abdallah, Assiut University

Brief 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

Condition or disease Intervention/treatment
Eye Diseases Renal Impairment Type2 Diabetes Device: fundoscope

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Frequency Of Eye Problems In Type 2 Diabetes With Chronic Kidney Disease
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330054


Contacts
Layout table for location contacts
Contact: Mohamed R Abdallah 00201011770935 ext 0020952600399 drmramadanas33@gmail.com

Sponsors and Collaborators
Mohammed Ramadan Abdallah
Assiut University
Investigators
Layout table for investigator information
Study Chair: Lobna F El-Toony, MD Assiut University
Layout table for additonal information
Responsible Party: Mohammed Ramadan Abdallah, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03330054    
Other Study ID Numbers: AssiutU MRAbdallah
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Eye Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases