- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468152
Advanced Glycation End Products Are Associated With Diabetic Macular Edema
Increased Dietary Intake and Serum Levels of Advanced Glycation End Products Are Associated With Diabetic Macular Edema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a cross-sectional study was carried out in the Hacettepe University Hospital, Department of Ophthalmology, between July 2018 and February 2019.
While benefiting from the results of the previous studies, the sample size of the research was type 1 error level α = 0.05 and type 2 level β = 0.20. The power analysis was statistically calculated using NCCS PAS 11 program. The present study was conducted with 90 patients: 50 case-patients (DM with DME) and 40 control patients (DM without DME). Excluded from the study were those under the age of 18 years, with no diagnosis of Type 2 DM, without any anti-diabetic agent, with any disease other than DME and DR that may affect the retina, with any disease that may affect the retina for the control group, with corneal, lens or vitreous opacification preventing Optical coherence tomography (OCT) withdrawal, with any systemic disease other than DM and hypertension, with a history of eye surgery, and with blindness or infection in the eye, along with those recently diagnosed with diabetes (<1 year) and those with special diets.
This the study was conducted in accordance with the Declaration of Helsinki Ethical Principles.
OCT withdrawals and CFT evaluations of those included in the study were made by the doctor and directed to the dietician (researcher). Demographic data and the dietary habits were collected through standardized face-to-face interviewer-assisted questionnaires. The bodyweight and height of patients were measured using a calibrated body composition analyser and weight scales by researcher. BMI was evaluated based on the WHO classification. Waist and hip circumference was also measured and evaluated in terms of high risk of developing chronic diseases. Hypothesis: If the waist/hip ratio is ≥0.85 for women and ≥0.90 for men, the risk of developing chronic diseases increases.
Diabetic macular edema (DME) Examination After a detailed systemic and ophthalmological history was taken from all subjects by the doctor, the best-corrected visual acuity level was measured using an ETDRS chart. A fundus examination was performed with a 90 D lens after anterior segment examination and pupil dilation with a biomicroscope. A spectral-domain OCT (Spectralis OCT, Heidelberg Engineering, Heidelberg, Germany) was applied for the evaluation of CFT. After a minimum of eight hours of fasting, approximately 5 ml of peripheral venous blood was collected from the antecubital region in the HÜTF Ophthalmology Clinic between 08:00 and 10:00.
Assessment of dietary intake and dietary AGEs The dietary intake of participants was assessed using a validated quantitative food frequency questionnaire (QFFQ) (including about 110 food items take 20-25 minutes to complete). Foods were classified into eight categories: dairy products, meat products, fruits, vegetables, bread and cereals, beverages, and desserts. Also, questions were asked to patients about traditional cooking methods to calculate dietary AGE intakes. Such as what cooking methods do they cook the foods? How long do they cook the food? Standardized food recipes for Turkey and the Nutrition Information System (BEBIS) program were used to calculate the average daily energy and nutrient intake for each participant. Meanwhile, to assess dietary AGEs from the QFFQ, each food's contribution to dAGEs intake was calculated based on the Advance Glycation End Products in Foods Table published by the Uribarri et al., which comprises data on 549 food items.
Sample Collection and Analysis The serum samples collected during the research were delivered to the laboratory while preserving the cold chain. The enzyme-labeled immune "Enzyme-Linked Immunosorbent Assay (ELISA)" test was performed with biologists of the company using a Biotek 800TS device. While analyzing the samples, Human CML Elisa Kit 96 tests for serum AGE and Human RAGE Elisa Kit 96 test kits for serum RAGE were used. Carboxymethyl lysine (CML) was considered as the AGE parameter, being the most easily detected and the most abundant type of AGE in humans. The minimum detectable dose of CML in humans is typically less than 15.6 pg/ml.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06230
- Hacettepe University Hospital Department of Ophthalmology Polyclinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Included from the study were those over the age of 18 years, with diagnosis of Type 2 DM.
Exclusion Criteria:
- Excluded from the study were those under the age of 18 years, with no diagnosis of Type 2 DM, without any anti-diabetic agent, with any disease other than DME and DR that may affect the retina, with any disease that may affect the retina for the control group, with corneal, lens or vitreous opacification preventing Optical coherence tomography (OCT) withdrawal, with any systemic disease other than DM and hypertension, with a history of eye surgery, and with blindness or infection in the eye, along with those recently diagnosed with diabetes (<1 year) and those with special diets.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Case
|
Optical coherence tomography (OCT) withdrawals and central foveal thickness (CFT) evaluations of those included in the study were made by the doctor and directed to the dietician (researcher).
The dietary intake of participants was assessed using a validated quantitative food frequency questionnaire (QFFQ) (21).
The total food intake was then converted to total nutrient intake based on the food's nutrient profile.
Standardized food recipes for Turkey and the Nutrition Information System (BEBIS) program, which is a food composition database for nutrient estimation, were used to determine the average daily energy and nutrient intake for each participant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
We hypothesize that the AGEs levels of the DME group would found be higher than in the control group.
Time Frame: 3 months
|
The serum samples collected during the research were delivered to the laboratory while preserving the cold chain.
The enzyme-labelled immune "Enzyme-Linked Immunosorbent Assay (ELISA)" test was performed with biologists of the company using a Biotek 800TS device.
While analyzing the samples, Human CML Elisa Kit 96 tests for serum AGE is used.
Carboxymethyl lysine (CML) was considered as the AGE parameter, being the most easily detected and the most abundant type of AGE in humans.
The minimum detectable dose of CML in humans is typically less than 15.6 pg/ml.
|
3 months
|
We hypothesize that the dietary intake of AGEs wolud be higher in the DME group.
Time Frame: 1 month
|
The dietary intake of participants was assessed using a validated quantitative food frequency questionnaire (QFFQ).
The total food intake was then converted to total nutrient intake based on the food's nutrient profile.
Standardized food recipes for Turkey and the Nutrition Information System (BEBIS) program, which is a food composition database for nutrient estimation, were used to determine the average daily energy and nutrient intake for each participant.
These values were subsequently compared with the recommended daily allowance values to determine the status of meeting energy and nutrient requirements.
After that, the percentages meeting the requirements were calculated.
Meanwhile, to assess dietary AGEs from the QFFQ, each food's contribution to dAGEs intake was calculated based on the Advance Glycation End Products in Foods Table published by the Uribarri et al.
|
1 month
|
We hypothesize that neck circumference correlated significantly with DME.
Time Frame: 1 month
|
The neck circumference of the participants will be measured by the researcher Sedat Arslan with a calibrated tape measure on a centimeter scale.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
We hypothesize that the sRAGE levels were higher in the DME group.
Time Frame: 3 months
|
The serum samples collected during the research were delivered to the laboratory while preserving the cold chain.
The enzyme-labelled immune "Enzyme-Linked Immunosorbent Assay (ELISA)" test was performed with biologists of the company using a Biotek 800TS device.
While analyzing the samples,Human RAGE Elisa Kit 96 test kits for serum RAGE were used.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sibel Kadayıfçılar, Prof.Dr., Hacettepe University
- Study Director: Gülhan Samur, Prof.Dr., Hacettepe University
- Study Chair: Dila Kırağı, Dr., Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 18/562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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