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

Completed

• Conditions: Diabetic Retinopathy; Hormones; Diabetes Mellitus
• Interventions: Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy

• Registration Number: NCT04930224
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

Observational, comparative, cross-sectional study

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 Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-04-25
• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy individuals	The effect of GPER-1 on the formation of diabetic retinopathy	40 healthy persons
Proliferative Diabetic retinopathy	The effect of GPER-1 on the formation of diabetic retinopathy	40 patients with proliferative diabetic retinopathy
Non-Proliferative Diabetic retinopathy	The effect of GPER-1 on the formation of diabetic retinopathy	40 patients with non-proliferative diabetic retinopathy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Abdullah Beyoğlu; 🇹🇷 Kahramanmaras, None Selected, Turkey