Gestational Diabetes Mellitus in PregnancyNCT05528393
Prolactin and FGF21 in Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus in Pregnancy and Hyperprolactinemia Pregnancy, run by Shen Qu at 1 site in China.
Trial summary
Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. 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
- Gestational Diabetes Mellitus in Pregnancy, Hyperprolactinemia Pregnancy
- What is being tested?
- Blood sampling
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Dec 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who met the above criteria were enrolled
Who may be able to join
- aged 18 to 45 years
- completed a 75-g oral glucose tolerance test (OGTT)
- females with pregnancy
Who cannot join
- severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism
- mental illness
- genetic disease
- current or previous treatment that might affect PRL and insulin secretion
- diabetes before pregnancy
- loss to follow-up, or withdrawal from the study
- unable to understand and comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, 200072
Shen Qu, PhD, +862166301064, qushencn@hotmail.com
About this study
Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. The investigators aimed to explore the possible influence of serum PRL within or without normal range on the development of GDM.
- Being tested
- Blood sampling
- Keywords
- Gestational Diabetes Mellitus, Prolactin, Insulin resistance, Fibroblast growth factor 21
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
blood sampling
| Study group | Role | What they receive |
|---|---|---|
| GDM and Non-GDM | Not described Receives: Diagnostic Test: Blood sampling | |
| Pregnant group and non-pregnant group | Not described Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes mellitus (GDM)
GDM is defined as a glucose intolerance resulting in hyperglycaemia of variable severity with onset during pregnancy. It can be diagnosed by the criteria: a fasting plasma glucose (FPG) concentration of O126 mg/dl on two separate occasions or a random blood glucose concentration of O200 mg/dl on two separate occasions.
Measured: 2019-2023
PRL
serum prolactin level
Measured: 2019-2023
Secondary outcomes (3)
Insulin resistance (IR)
It was considered to be IR if HOMA-IR >2.5
Measured: 2019-2023
HOMA-IR
It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5
Measured: 2019-2023
OGTT
OGTT was performed after an overnight fasting in each patient and blood samples were taken at 0, 30, 60, 120, and 180 min to determine the concentrations of plasma glucose.
Measured: 2019-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Jan 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Qu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Qu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528393
- Sponsor's protocol ID
- gestational diabetes mellitus
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolactin and FGF21 in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05528393
- Acronym / sponsor ID
- gestational diabetes mellitus
- Keywords
- Gestational Diabetes Mellitus, Prolactin, Insulin resistance, Fibroblast growth factor 21
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shen QuUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Sep 2022 (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.
Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. The investigators aimed to explore the possible influence of serum PRL within or without normal range on the development of GDM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM and Non-GDM | – | Diagnostic Test: Blood sampling |
| Pregnant group and non-pregnant group | – | Diagnostic Test: Blood sampling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who met the above criteria were enrolled
Key inclusion criteria (3 listed)
- aged 18 to 45 years
- completed a 75-g oral glucose tolerance test (OGTT)
- females with pregnancy
Key exclusion criteria (7 listed)
- severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism
- mental illness
- genetic disease
- current or previous treatment that might affect PRL and insulin secretion
- diabetes before pregnancy
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 |
|---|---|---|
| Blood samplingblood sampling | Diagnostic test | GDM and Non-GDM, Pregnant group and non-pregnant group |
Primary outcome
Gestational diabetes mellitus (GDM)
Time frame: 2019-2023
GDM is defined as a glucose intolerance resulting in hyperglycaemia of variable severity with onset during pregnancy. It can be diagnosed by the criteria: a fasting plasma glucose (FPG) concentration of O126 mg/dl on two separate occasions or a random blood glucose concentration of O200 mg/dl on two separate occasions.
PRL
Time frame: 2019-2023
serum prolactin level
3 secondary outcomes
Insulin resistance (IR)
Time frame: 2019-2023
HOMA-IR
Time frame: 2019-2023
OGTT
Time frame: 2019-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
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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.
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 Gestational Diabetes Mellitus in Pregnancy and Hyperprolactinemia Pregnancy, run by Shen Qu at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 6 Sep 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes mellitus (GDM) (time frame: 2019-2023). The study lists 2 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 6 Sep 2022.