Gestational Diabetes MellitusNCT03816605
FGF19 and the Expression of IRS-1 and GLUT-1 in Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Insulin resistance plays a key role in the development of gestational diabetes mellitus(GDM). As the largest endocrine organ and the transport intermediary of maternal-fetal nutrient and a large of hormone and enzymes, placenta not only plays an important role in insulin resistance, but also have a profound effect on… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Apr 2016
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: University hospital
Who may be able to join
- Women who choose to terminate pregnancy because of maternal factors in the First Affiliated Hospital of Sun Yat-sen University at the 6-10 weeks of gestation.
Who cannot join
- Younger than 18 years old;
- Older than 40 years old;
- Diagnosed DM before pregnancy;
- Complicated with other diseases such as GDM, insulin resistance, obesity and related endocrine diseases, etc.;
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Effects of Fibroblast Growth Factors 19 on the Expression of Insulin Receptor Substrate-1/Glucose Transporter-1 in Trophoblast Cells Cultured in High Glucose
Insulin resistance plays a key role in the development of gestational diabetes mellitus(GDM). As the largest endocrine organ and the transport intermediary of maternal-fetal nutrient and a large of hormone and enzymes, placenta not only plays an important role in insulin resistance, but also have a profound effect on fetal growth and development.
Insulin receptor substrate(IRS)-1, as a key signaling protein, plays vital role in the downstream of insulin receptor signaling pathway. Many studies have suggested that the central part of insulin resistance may be the insulin receptor substrate defect and the abnormal expression of the gene or protein of IRS-1 is one of the molecular mechanisms of the dysfunction of the insulin signaling pathway. The expression of IRS-1 and its tyrosine phosphorylated protein decreased abnormally in placenta, skeletal muscle and adipose tissue of GDM patients, which might be a significant cause to insulin resistance in GDM.
Read more
Besides, glucose transporter-1(GLUT-1), which may play a major role in the glucose transporter in the placenta. The increase of blood glucose in patients with GDM has apparent up-regulating effect on the expression of GLUT-1 in the placenta, which is associated the development of offspring.
The investigators' previous study showed that FGF19 in serum, placenta and musculus rectus abdominis was significantly decreased in patients with GDM, and was related to insulin resistance. Thus, the investigators speculate that the abnormal expression of FGF19 may be involved in the development of insulin resistance in GDM patients and disorder of carbohydrate and lipid metabolism.
In the present study, the investigators will further investigate the effect of FGF19 on the expression of IRS-1/GLUT-1 in cultured trophoblast cells of high glucose, and probe into the effect of FGF19 on the insulin resistance and glucose transport.
Read the detailed description
Women who choose to terminate pregnancy because of maternal factors at the first and second trimester, or delivered at term in the First Affiliated Hospital of Sun Yat-sen University were enrolled in the study.
Samples for measurement were obtained from women undergoing induced abortion or caesarean section. The villous trophoblast extracted from the placental villus were treated with recombinant FGF19, high glucose medium or both recombinant FGF19 and high glucose medium or neither. By the end of culture, mRNA and protein expression levels of IRS-1/GLUT-1 were investigated with real-time quantitative polymerase chain reaction (qRT-PCR) and western-blot, respectively. Clinical data were collected and analyzed.
Data were analyzed by SPSS20.0 database. The results were expressed as mean ± standard deviations, median or rate. Differences between groups were assessed by Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate. P values of <0.05 were considered significant.
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- GDM, IRS-1, GLUT-1
- 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 |
|---|---|---|
| control | Cells were cultured in the basic medium containing 2× penicillin and streptomycin antibody. | |
| Recombinant FGF19 | Cells were cultured in the basic medium with recombinant FGF19 at concentration of 100ng/ml. | |
| High-glucose | Cells were cultured in the high-glucose medium at concentration of 25mM. | |
| FGF19 and HG | Cells were cultured in the medium with both recombinant FGF19 and high-glucose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of IRS-1 and GLUT-1 in different group
concentration of IRS-1 and GLUT-1 in mmol/l
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zilian Wang, M.D.,PhD, Study director, O&G Department of the 1st affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816605
- Sponsor's protocol ID
- FGF19
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fibroblast Growth Factors 19 on the Expression of Insulin Receptor Substrate-1/Glucose Transporter-1 in Trophoblast Cells Cultured in High Glucose
- ClinicalTrials.gov ID
- NCT03816605
- Acronym / sponsor ID
- FGF19
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- GDM, IRS-1, GLUT-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jan 2019 (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.
Insulin resistance plays a key role in the development of gestational diabetes mellitus(GDM). As the largest endocrine organ and the transport intermediary of maternal-fetal nutrient and a large of hormone and enzymes, placenta not only plays an important role in insulin resistance, but also have a profound effect on fetal growth and development.
Insulin receptor substrate(IRS)-1, as a key signaling protein, plays vital role in the downstream of insulin receptor signaling pathway. Many studies have suggested that the central part of insulin resistance may be the insulin receptor substrate defect and the abnormal expression of the gene or protein of IRS-1 is one of the molecular mechanisms of the dysfunction of the insulin signaling pathway. The expression of IRS-1 and its tyrosine phosphorylated protein decreased abnormally in placenta, skeletal muscle and adipose tissue of GDM patients, which might be a significant cause to insulin resistance in GDM.
Besides, glucose transporter-1(GLUT-1), which may play a major role in the glucose transporter in the placenta. The increase of blood glucose in patients with GDM has apparent up-regulating effect on the expression of GLUT-1 in the placenta, which is associated the development of offspring.
The investigators' previous study showed that FGF19 in serum, placenta and musculus rectus abdominis was significantly decreased in patients with GDM, and was related to insulin resistance. Thus, the investigators speculate that the abnormal expression of FGF19 may be involved in the development of insulin resistance in GDM patients and disorder of carbohydrate and lipid metabolism.
In the present study, the investigators will further investigate the effect of FGF19 on the expression of IRS-1/GLUT-1 in cultured trophoblast cells of high glucose, and probe into the effect of FGF19 on the insulin resistance and glucose transport.
Detailed description
Women who choose to terminate pregnancy because of maternal factors at the first and second trimester, or delivered at term in the First Affiliated Hospital of Sun Yat-sen University were enrolled in the study.
Samples for measurement were obtained from women undergoing induced abortion or caesarean section. The villous trophoblast extracted from the placental villus were treated with recombinant FGF19, high glucose medium or both recombinant FGF19 and high glucose medium or neither. By the end of culture, mRNA and protein expression levels of IRS-1/GLUT-1 were investigated with real-time quantitative polymerase chain reaction (qRT-PCR) and western-blot, respectively. Clinical data were collected and analyzed.
Data were analyzed by SPSS20.0 database. The results were expressed as mean ± standard deviations, median or rate. Differences between groups were assessed by Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate. P values of <0.05 were considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | – | –Cells were cultured in the basic medium containing 2× penicillin and streptomycin antibody. |
| Recombinant FGF19 | – | –Cells were cultured in the basic medium with recombinant FGF19 at concentration of 100ng/ml. |
| High-glucose | – | –Cells were cultured in the high-glucose medium at concentration of 25mM. |
| FGF19 and HG | – | –Cells were cultured in the medium with both recombinant FGF19 and high-glucose. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University hospital
Key inclusion criteria (1 listed)
- Women who choose to terminate pregnancy because of maternal factors in the First Affiliated Hospital of Sun Yat-sen University at the 6-10 weeks of gestation.
Key exclusion criteria (4 listed)
- Younger than 18 years old;
- Older than 40 years old;
- Diagnosed DM before pregnancy;
- Complicated with other diseases such as GDM, insulin resistance, obesity and related endocrine diseases, etc.;
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
Expression of IRS-1 and GLUT-1 in different group
Time frame: six months
concentration of IRS-1 and GLUT-1 in mmol/l
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 25 Jan 2019.
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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.
Zilian Wang, M.D.,PhD study director
O&G Department of the 1st affiliated hospital of Sun Yat-sen 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 Gestational Diabetes Mellitus, run by First Affiliated Hospital, Sun Yat-Sen University 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 1 inclusion and 4 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 25 Jan 2019. 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?
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?
Expression of IRS-1 and GLUT-1 in different group (time frame: six months). 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 25 Jan 2019.