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

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: Completed
• Conditions: Diabetes Mellitus; Diabetic Retinopathy; Hormones
• Intervention / Treatment: Diagnostic test: The effect of GPER-1 on the formation of diabetic retinopathy

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: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
G receptor-mediated protein-1 (GPER-1)	Variation of GPER-1 during the development of diabetic retinopathy	Baseline
Oxidative/antioxidative stress markers (malondialdehyde [MDA])	Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy	Baseline
Oxidative/antioxidative stress markers (catalase [CAT])	Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy	Baseline
Oxidative/antioxidative stress markers (superoxide dismutase [SOD]	Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy	Baseline
Thyroid stimulating hormone (TSH)	Variation of TSH during the development of diabetic retinopathy	Baseline
Progesterone	Variation of progeterone during the development of diabetic retinopathy	Baseline
oestradiol	Variation of oestradiol during the development of diabetic retinopathy	Baseline

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Study Chair: Abdullah Beyoğlu, MD, Kahramanmaraş Sütçü İmam University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): April 25, 2020

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: oxidative stress; progesterone; Diabetic retinopathy; TSH; oestradiol; GPER-1; neuronal damage.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID 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