NCT04930224

Brief Summary

Observational, comparative, cross-sectional study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

June 14, 2021

Last Update Submit

June 17, 2021

Conditions

Diabetes MellitusDiabetic RetinopathyHormones

Keywords

Diabetic retinopathyGPER-1oestradiolprogesteroneTSHoxidative stressneuronal damage.

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (3)

Proliferative Diabetic retinopathy

40 patients with proliferative diabetic retinopathy

Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy

Non-Proliferative Diabetic retinopathy

40 patients with non-proliferative diabetic retinopathy

Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy

Healthy individuals

40 healthy persons

Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy

Interventions

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

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

Healthy individualsNon-Proliferative Diabetic retinopathyProliferative Diabetic retinopathy

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People who applied to the tertiary eye outpatient clinic

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdullah Beyoğlu

Kahramanmaraş, None Selected, 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Abdullah Beyoğlu, MD

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist of Prof

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

July 1, 2019

Primary Completion

January 31, 2020

Study Completion

April 25, 2020

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

TU(1)