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Diabetic Macular EdemaNCT04468152

Advanced Glycation End Products Are Associated With Diabetic Macular Edema

A study testing Dietary habits and intake in people with Diabetic Macular Edema and Diabetes Mellitus, Type 2, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dietary habits and intake
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Jul 2018to 10 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University Hospital Department of Ophthalmology Polyclinic

    Ankara, Altındağ, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Dietary habits and intake
Keywords
advanced glycation end products, diabetic macular edema, nutrition
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary habits and intakeBehavioural

    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.

Study groups in NCT04468152
Study groupRoleWhat they receive
CaseExperimentalNot described
Receives: Behavioral: Dietary habits and intake
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 1 month

  3. 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.

    Measured: 1 month

Secondary outcomes (1)
  1. We hypothesize that the sRAGE levels were higher in the DME 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 RAGE Elisa Kit 96 test kits for serum RAGE were used.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start7 Jul 2018
  3. Primary completion10 Jan 2019
  4. Study completion10 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468152
Sponsor's protocol ID
GO 18/562
Status last verified
Jul 2020
First submitted
3 Jul 2020
Last updated
13 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary habits and intake in people with Diabetic Macular Edema and Diabetes Mellitus, Type 2, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

We hypothesize that the AGEs levels of the DME group would found be higher than in the control group. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.

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