Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients

June 17, 2021 updated by: Abdullah Beyoğlu, Kahramanmaras Sutcu Imam University

Comparing the Impact of Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients and Healthy Individuals: A Pilot Study

Observational, comparative, cross-sectional study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was conducted on G protein-mediated estrogen receptor 1 (GPER-1), which is thought to be effective in preventing the development of diabetic retinopathy (DR). There are studies proving that GPER-1 prevents neuroprotective effects and vascular pathology in many tissues. In the study, serum GPER-1 and oxidative stress biomarker levels were compared in diabetic patients and healthy control groups. GPER-1 was found to be significantly increased in diabetic patients. In addition, a positive correlation was found with oxidant markers. This may lead to new treatment models in the future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • None Selected
      • Kahramanmaras, None Selected, Turkey, 46040
        • Abdullah Beyoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People who applied to the tertiary eye outpatient clinic

Description

Inclusion Criteria:

  • 40 individuals were required to have Proliferative Diabetic Retinopathy (PDR);
  • 40 were required to have Non-PDR;
  • 40 were required to be healthy, without any systemic disease.

Exclusion Criteria:

  • Glaucoma,
  • Ocular trauma sequelae,
  • Pathological myopia,
  • Non-diabetic retinopathy,
  • A history of previous ocular surgery,
  • Endocrine disorders (e.g.,thyroidopathy, adrenal gland disorders, pituitary pathologies),
  • Opacities interfering with fundus examination (e.g., corneal opacity, lens opacity, vitreous cloudiness other than diabetic haemorrhage).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Proliferative Diabetic retinopathy
40 patients with proliferative diabetic retinopathy
Diagnostic test: The effect of GPER-1 on the formation of diabetic retinopathy
Demonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models
Non-Proliferative Diabetic retinopathy
40 patients with non-proliferative diabetic retinopathy
Diagnostic test: The effect of GPER-1 on the formation of diabetic retinopathy
Demonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models
Healthy individuals
40 healthy persons
Diagnostic test: The effect of GPER-1 on the formation of diabetic retinopathy
Demonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
G receptor-mediated protein-1 (GPER-1)
Time Frame: Baseline
Variation of GPER-1 during the development of diabetic retinopathy
Baseline
Oxidative/antioxidative stress markers (malondialdehyde [MDA])
Time Frame: Baseline
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Baseline
Oxidative/antioxidative stress markers (catalase [CAT])
Time Frame: Baseline
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Baseline
Oxidative/antioxidative stress markers (superoxide dismutase [SOD]
Time Frame: Baseline
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Baseline
Thyroid stimulating hormone (TSH)
Time Frame: Baseline
Variation of TSH during the development of diabetic retinopathy
Baseline
Progesterone
Time Frame: Baseline
Variation of progeterone during the development of diabetic retinopathy
Baseline
oestradiol
Time Frame: Baseline
Variation of oestradiol during the development of diabetic retinopathy
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Abdullah Beyoğlu, MD, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • (Project no: 2019/5-24 M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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