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Completed

NCT Number: NCT04930224

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

Observational, comparative, cross-sectional study

Completed

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Hormones Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdullah Beyoğlu

Kahramanmaraş, None Selected, 46040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

The effect of GPER-1 on the formation of diabetic retinopathy

Diagnostic Test

Demonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models

Primary outcomes

  1. G receptor-mediated protein-1 (GPER-1)

    Time frame: Baseline

    Variation of GPER-1 during the development of diabetic retinopathy

  2. Oxidative/antioxidative stress markers (malondialdehyde [MDA])

    Time frame: Baseline

    Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy

  3. Oxidative/antioxidative stress markers (catalase [CAT])

    Time frame: Baseline

    Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy

  4. Oxidative/antioxidative stress markers (superoxide dismutase [SOD]

    Time frame: Baseline

    Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy

  5. Thyroid stimulating hormone (TSH)

    Time frame: Baseline

    Variation of TSH during the development of diabetic retinopathy

  6. Progesterone

    Time frame: Baseline

    Variation of progeterone during the development of diabetic retinopathy

  7. oestradiol

    Time frame: Baseline

    Variation of oestradiol during the development of diabetic retinopathy

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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