NCT04468152|CompletedDMC
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
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Increased Dietary Intake and Serum Levels of Advanced Glycation End Products Are Associated With Diabetic Macular Edema
Sponsor study identifier
interventional
90
1 country
1
Study Start
July 7, 2018
Actual (reported)Primary Completion
January 10, 2019
Actual (reported)Study Completion
January 10, 2019
Actual (reported)Diabetic macular edema can develop at all stages of diabetic retinopathy, causing visual impairment and blindness. Modern diets are high in advanced glycation end products (dAGEs), derived from processing methods, exerting a pivotal role in promoting diabetic retinopathy risk. In this cross-sectional study, we investigate the relationship between dietary and serum levels of AGEs and DME in type 2 diabetic subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 10, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2018
Actual (reported)January 10, 2019
Actual (reported)January 10, 2019
Actual (reported)July 3, 2020
Actual (reported)July 13, 2020
Actual (reported)We hypothesize that the AGEs levels of the DME group would found be higher than in the control group.
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.
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 the sRAGE levels were higher in the DME group.
3 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hacettepe University Hospital Department of Ophthalmology Polyclinic
Ankara, Altındağ, 06230, Turkey (Türkiye)
Sibel Kadayıfçılar, Prof.Dr.
Hacettepe University
Gülhan Samur, Prof.Dr.
Hacettepe University
Dila Kırağı, Dr.
Hacettepe University
90 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2020
First Posted
July 13, 2020
Study Start
July 7, 2018
Actual (reported)The Effect of the Interdisciplinary Care Approach on General Health Parameters in Older Adults With Type 2 Diabetes
We hypothesize that neck circumference correlated significantly with DME.
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
Contact the study team to confirm eligibility.
Primary Completion
January 10, 2019
Actual (reported)Study Completion
January 10, 2019
Actual (reported)Last Updated
July 13, 2020
Record last verified: 2020-07
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