Diabetes MellitusNCT04930224
Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients
An observational study of Diabetes Mellitus and Diabetic Retinopathy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Observational, comparative, cross-sectional study Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Hormones
- What is being tested?
- The effect of GPER-1 on the formation of diabetic retinopathy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 25 Apr 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who applied to the tertiary eye outpatient clinic
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdullah Beyoğlu
Kahramanmaraş, None Selected, 46040
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Hormones
- Being tested
- The effect of GPER-1 on the formation of diabetic retinopathy
- Keywords
- Diabetic retinopathy, GPER-1, oestradiol, progesterone, TSH, oxidative stress, neuronal damage.
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Proliferative Diabetic retinopathy | 40 patients with proliferative diabetic retinopathy Receives: Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy | |
| Non-Proliferative Diabetic retinopathy | 40 patients with non-proliferative diabetic retinopathy Receives: Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy | |
| Healthy individuals | 40 healthy persons Receives: Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
G receptor-mediated protein-1 (GPER-1)
Variation of GPER-1 during the development of diabetic retinopathy
Measured: Baseline
Oxidative/antioxidative stress markers (malondialdehyde [MDA])
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Measured: Baseline
Oxidative/antioxidative stress markers (catalase [CAT])
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Measured: Baseline
Oxidative/antioxidative stress markers (superoxide dismutase [SOD]
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Measured: Baseline
Thyroid stimulating hormone (TSH)
Variation of TSH during the development of diabetic retinopathy
Measured: Baseline
Progesterone
Variation of progeterone during the development of diabetic retinopathy
Measured: Baseline
oestradiol
Variation of oestradiol during the development of diabetic retinopathy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jul 2019
- Primary completion31 Jan 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Beyoğlu, Kahramanmaras Sutcu Imam University
- Investigators
- Abdullah Beyoğlu, MD, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930224
- Sponsor's protocol ID
- (Project no: 2019/5-24 M
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Impact of Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients and Healthy Individuals: A Pilot Study
- ClinicalTrials.gov ID
- NCT04930224
- Acronym / sponsor ID
- (Project no: 2019/5-24 M
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Hormones
- Keywords
- Diabetic retinopathy, GPER-1, oestradiol, progesterone, TSH, oxidative stress, neuronal damage.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proliferative Diabetic retinopathy | – | Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy40 patients with proliferative diabetic retinopathy |
| Non-Proliferative Diabetic retinopathy | – | Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy40 patients with non-proliferative diabetic retinopathy |
| Healthy individuals | – | Diagnostic Test: The effect of GPER-1 on the formation of diabetic retinopathy40 healthy persons |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who applied to the tertiary eye outpatient clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Glaucoma,
- Ocular trauma sequelae,
- Pathological myopia,
- Non-diabetic retinopathy,
- A history of previous ocular surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The effect of GPER-1 on the formation of diabetic retinopathyDemonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models | Diagnostic test | Healthy individuals, Non-Proliferative Diabetic retinopathy, Proliferative Diabetic retinopathy |
Primary outcome
G receptor-mediated protein-1 (GPER-1)
Time frame: Baseline
Variation of GPER-1 during the development of diabetic retinopathy
Oxidative/antioxidative stress markers (malondialdehyde [MDA])
Time frame: Baseline
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Oxidative/antioxidative stress markers (catalase [CAT])
Time frame: Baseline
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Oxidative/antioxidative stress markers (superoxide dismutase [SOD]
Time frame: Baseline
Variation of oxidative/antioxidative stress markers during the development of diabetic retinopathy
Thyroid stimulating hormone (TSH)
Time frame: Baseline
Variation of TSH during the development of diabetic retinopathy
Progesterone
Time frame: Baseline
Variation of progeterone during the development of diabetic retinopathy
oestradiol
Time frame: Baseline
Variation of oestradiol during the development of diabetic retinopathy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah Beyoğlu, MD study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetic Retinopathy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
G receptor-mediated protein-1 (GPER-1) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.