Gestatiaonl Diabetes MellitusNCT07750431
The Role of Progesterone Membrane Receptors in the Development of Gestational Diabetes Mellitus
An observational study of Gestatiaonl Diabetes Mellitus, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the potential roles of PGRMC1, PGRMC2, and PAQR family membrane progesterone receptors in the pathophysiology of gestational diabetes mellitus by comparing their expression levels in placentas from pregnancies complicated by gestational diabetes mellitus with those from healthy… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Jan 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women aged 18-45 years delivering at Samsun City Hospital will be enrolled. The study population will consist of women with singleton pregnancies complicated by gestational diabetes mellitus and healthy pregnant women with appropriate fetal growth serving as the control group. Placental tissue samples will be collected immediately after delivery for molecular analysis.
Inclusion Criteria: Healthy women with singleton pregnancies 18-45 years pregnant gestational diabetes mellitus -
Exclusion Criteria: Multiple pregnancies pregnant women under the age of 18 or over the age of 45
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Progesterone Membrane Receptors in the Development of Gestational Diabetes Mellitus; A Prospective Observational Case-Control Study
The aim of this study is to investigate the potential roles of PGRMC1, PGRMC2, and PAQR family membrane progesterone receptors in the pathophysiology of gestational diabetes mellitus by comparing their expression levels in placentas from pregnancies complicated by gestational diabetes mellitus with those from healthy pregnancies.
Read the detailed description
Gestational Diabetes Mellitus (GDM) is a medical condition characterized by glycemic intolerance that is detected at any time during pregnancy but was not present prior to it. It can lead to adverse health outcomes. Global data from 2021 indicate that 21.1 million live births involved women (aged 20-49) who experienced some form of diabetes during pregnancy (1). The fundamental mechanism underlying GDM pathophysiology is not yet fully understood; however, it generally results from pancreatic β-cell dysfunction arising from a state of chronic insulin resistance during pregnancy (2). Progesterone is a steroid that plays a central role in maintaining pregnancy; it suppresses uterine contractions and supports fetal immune tolerance (3). Progesterone exerts its effects not only through classical nuclear progesterone receptors but also via membrane-associated progesterone receptors (mPRs). These receptors include PGRMC1, PGRMC2, and the PAQR family (PAQR7, PAQR8, etc.) (4). Paula et al. demonstrated that the elimination of progesterone receptors in β-cells improved β-cell function and glucose tolerance in female mice during pregnancy and diet-induced insulin resistance (5). Furthermore, Picard et al. reported an improvement in glucose homeostasis-driven by β-cell proliferation-in progesterone receptor knockout mice (6). However, data regarding the expression levels of these receptors in the placentas of patients who develop gestational diabetes mellitus remain limited. In light of all this information, the scope of our study is to compare the expression levels of progesterone membrane receptors in placentas from pregnancies complicated by gestational diabetes mellitus and healthy pregnancies, and to determine the roles of these receptors in the pathophysiology of gestational diabetes mellitus.
- Conditions
- Gestatiaonl Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, progesterone membran receptors
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes mellitus group | Control Group | |
| Gestational diabetes mellitus group and control group | Gestational diabetes mellitusGroupPregnant women diagnosed with gestational diabetes who will undergo placental tissue collection at delivery for molecularanalysis. Healthy Control GroupHealthy pregnant women with normal oral glucose tolerence test result who will undergo placental tissue collection at delivery for molecular analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Placental PGRMC1,PGRMC2 and PAQR mRNA expression levels
Relative placental mRNA expression levels of PGRMC1, PGRMC2 and PAQR family receptors measured by quantitative real-time polymerase chain reaction (qRT-PCR) in placental tissue collected immedia
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestatiaonl 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
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEMRA EROGLU, Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750431
- Sponsor's protocol ID
- 2025/313
- Other IDs
- Samsun University
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Arck P, Hansen PJ, Mulac Jericevic B, Piccinni MP, Szekeres-Bartho J. Progesterone during pregnancy: endocrine-immune cross talk in mammalian species and the role of stress. Am J Reprod Immunol. 2007 Sep;58(3):268-79. doi: 10.1111/j.1600-0897.2007.00512.x.
PubMed 17681043
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Progesterone Membrane Receptors in the Development of Gestational Diabetes Mellitus; A Prospective Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT07750431
- Acronym / sponsor ID
- 2025/313
- Conditions
- Gestatiaonl Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, progesterone membran receptors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
The aim of this study is to investigate the potential roles of PGRMC1, PGRMC2, and PAQR family membrane progesterone receptors in the pathophysiology of gestational diabetes mellitus by comparing their expression levels in placentas from pregnancies complicated by gestational diabetes mellitus with those from healthy pregnancies.
Detailed description
Gestational Diabetes Mellitus (GDM) is a medical condition characterized by glycemic intolerance that is detected at any time during pregnancy but was not present prior to it. It can lead to adverse health outcomes. Global data from 2021 indicate that 21.1 million live births involved women (aged 20-49) who experienced some form of diabetes during pregnancy (1). The fundamental mechanism underlying GDM pathophysiology is not yet fully understood; however, it generally results from pancreatic β-cell dysfunction arising from a state of chronic insulin resistance during pregnancy (2). Progesterone is a steroid that plays a central role in maintaining pregnancy; it suppresses uterine contractions and supports fetal immune tolerance (3). Progesterone exerts its effects not only through classical nuclear progesterone receptors but also via membrane-associated progesterone receptors (mPRs). These receptors include PGRMC1, PGRMC2, and the PAQR family (PAQR7, PAQR8, etc.) (4). Paula et al. demonstrated that the elimination of progesterone receptors in β-cells improved β-cell function and glucose tolerance in female mice during pregnancy and diet-induced insulin resistance (5). Furthermore, Picard et al. reported an improvement in glucose homeostasis-driven by β-cell proliferation-in progesterone receptor knockout mice (6). However, data regarding the expression levels of these receptors in the placentas of patients who develop gestational diabetes mellitus remain limited. In light of all this information, the scope of our study is to compare the expression levels of progesterone membrane receptors in placentas from pregnancies complicated by gestational diabetes mellitus and healthy pregnancies, and to determine the roles of these receptors in the pathophysiology of gestational diabetes mellitus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes mellitus group | – | –Control Group |
| Gestational diabetes mellitus group and control group | – | –Gestational diabetes mellitusGroupPregnant women diagnosed with gestational diabetes who will undergo placental tissue collection at delivery for molecularanalysis. Healthy Control GroupHealthy pregnant women with normal oral glucose tolerence test result who will undergo placental tissue collection at delivery for molecular analysis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18-45 years delivering at Samsun City Hospital will be enrolled. The study population will consist of women with singleton pregnancies complicated by gestational diabetes mellitus and healthy pregnant women with appropriate fetal growth serving as the control group. Placental tissue samples will be collected immediately after delivery for molecular analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Placental PGRMC1,PGRMC2 and PAQR mRNA expression levels
Time frame: Delivery
Relative placental mRNA expression levels of PGRMC1, PGRMC2 and PAQR family receptors measured by quantitative real-time polymerase chain reaction (qRT-PCR) in placental tissue collected immedia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 17681043Arck P, Hansen PJ, Mulac Jericevic B, Piccinni MP, Szekeres-Bartho J. Progesterone during pregnancy: endocrine-immune cross talk in mammalian species and the role of stress. Am J Reprod Immunol. 2007 Sep;58(3):268-79. doi: 10.1111/j.1600-0897.2007.00512.x.
- Individual participant dataSharing planned: Yes
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Gestatiaonl Diabetes Mellitus
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.
SEMRA EROGLU study director
Samsun 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 Gestatiaonl Diabetes Mellitus, run by Samsun 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?
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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
1. Placental PGRMC1,PGRMC2 and PAQR mRNA expression levels (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07750431, which also lists 1 linked publication.
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 6 Aug 2026.