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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930224
• Other study ID #: (Project no: 2019/5-24 M
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: April 25, 2020

Study information

• Verified date: June 2021
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Observational, comparative, cross-sectional study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 25, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Hormones
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Abdullah Beyoglu	Kahramanmaras	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

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