Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Advanced Glycation End Products Are Associated With Diabetic Macular Edema

7 luglio 2020 aggiornato da: Sedat Arslan, Hacettepe University

Increased Dietary Intake and Serum Levels of Advanced Glycation End Products Are Associated With Diabetic Macular Edema

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Altındağ
      • Ankara, Altındağ, Tacchino, 06230
        • Hacettepe University Hospital Department of Ophthalmology Polyclinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Selezione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Controllo
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
We hypothesize that the AGEs levels of the DME group would found be higher than in the control group.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
We hypothesize that the sRAGE levels were higher in the DME group.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Sibel Kadayıfçılar, Prof.Dr., Hacettepe University
  • Direttore dello studio: Gülhan Samur, Prof.Dr., Hacettepe University
  • Cattedra di studio: Dila Kırağı, Dr., Hacettepe University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 luglio 2018

Completamento primario (Effettivo)

10 gennaio 2019

Completamento dello studio (Effettivo)

10 gennaio 2019

Date di iscrizione allo studio

Primo inviato

3 luglio 2020

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2020

Primo Inserito (Effettivo)

13 luglio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2020

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dietary habits and intake

Sottoscrivi