Advanced Glycation End Products Are Associated With Diabetic Macular Edema

NCT04468152 | Completed DMC

• 1 other identifier: GO 18/562
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Edema; Diabetes Mellitus, Type 2

Keywords

advanced glycation end products; diabetic macular edema; nutrition

Outcome Measures

Primary Outcomes (3)

• 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 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

Secondary Outcomes (1)

• We hypothesize that the sRAGE levels were higher in the DME group.

  3 months

Study Arms (2)

Case

EXPERIMENTAL

Behavioral: Dietary habits and intake

Control

NO INTERVENTION

Interventions

Dietary habits and intake BEHAVIORAL

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.

Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included from the study were those over the age of 18 years, with diagnosis of Type 2 DM.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Hospital Department of Ophthalmology Polyclinic

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sibel Kadayıfçılar, Prof.Dr.

  Hacettepe University

  STUDY CHAIR

• Gülhan Samur, Prof.Dr.

  Hacettepe University

  STUDY DIRECTOR

• Dila Kırağı, Dr.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 13, 2020
• Study Start: July 7, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)