Gestational DiabetesNCT03964987
Pancreatic Duodenal Homeobox Factor-1 (PDX-1) and Neurogenin-3 (NGN-3) in Gestational Diabetes
An observational study of Gestational Diabetes, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
Trial summary
Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM). The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in… 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
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2018to 31 Dec 2018
- How long will I take part?
- 9 Months
- 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: Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.
Who may be able to join
- Pregnant women older than 18 years old.
Who cannot join
- Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PDX-1 and NGN-3 Expression in Gestational Diabetes
Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM). The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in peripheral blood of pregnant women with GDM versus women with normal pregnancies.
Material and methods: This was a prospective, clinical and cross-sectional study, conforming two groups of pregnant women: a) patients with a healthy gestation and b) patients with GDM. Besides anthropometry and routine laboratorial test, real-time polymerase chain reaction (Real-Time PCR), was used to quantify the expression of PDX-1 and NGN-3.
Read the detailed description
Pregnant women attended in the Maternal-Fetal Medicine Service of the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, were invited to participate. Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition were excluded and those with incomplete clinical files were discarded from the final analysis. Two groups were integrated: a) patients with a healthy gestation and b) patients with GDM.
From all patients the next information was captured in an excell sheet: weight, height, Body Mass Index, blood pressure, albumin, creatinine, electrolytes, glucose, total cholesterol, triglycerides, transaminases and relative expression of PDX-1 and NGN-3.
- Conditions
- Gestational Diabetes
- Keywords
- PDX-1, NGN-3, Glucose
- 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 group | Women with normoevolutionary gestation. | |
| Problem group | Patients with GDM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARNm expression
Expression of the genes PDX-1 and NGN-3
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jan 2018
- Primary completion30 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Hugo Mendieta Zerón, PhD., Principal investigator, Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964987
- Sponsor's protocol ID
- 2016-09-481
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information will be available upon request.
Publications
Sandikci M, Karagenc L, Yildiz M. Changes on the Pancreas in Experimental Diabetes and the Effect of Lycopene on These Changes: Pdx-1, Ngn-3, and Nestin Expressions. Anat Rec (Hoboken). 2017 Dec;300(12):2200-2207. doi: 10.1002/ar.23687. Epub 2017 Sep 26.
PubMed 28921917Gu G, Dubauskaite J, Melton DA. Direct evidence for the pancreatic lineage: NGN3+ cells are islet progenitors and are distinct from duct progenitors. Development. 2002 May;129(10):2447-57. doi: 10.1242/dev.129.10.2447.
PubMed 11973276Wang L, Fan H, Zhou L, Wu Y, Lu H, Luo J. Altered expression of PGC-1alpha and PDX1 and their methylation status are associated with fetal glucose metabolism in gestational diabetes mellitus. Biochem Biophys Res Commun. 2018 Jun 18;501(1):300-306. doi: 10.1016/j.bbrc.2018.05.010. Epub 2018 May 7.
PubMed 29730292Plows JF, Stanley JL, Baker PN, Reynolds CM, Vickers MH. The Pathophysiology of Gestational Diabetes Mellitus. Int J Mol Sci. 2018 Oct 26;19(11):3342. doi: 10.3390/ijms19113342.
PubMed 30373146
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDX-1 and NGN-3 Expression in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03964987
- Acronym / sponsor ID
- 2016-09-481
- Conditions
- Gestational Diabetes
- Keywords
- PDX-1, NGN-3, Glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 May 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.
Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM). The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in peripheral blood of pregnant women with GDM versus women with normal pregnancies.
Material and methods: This was a prospective, clinical and cross-sectional study, conforming two groups of pregnant women: a) patients with a healthy gestation and b) patients with GDM. Besides anthropometry and routine laboratorial test, real-time polymerase chain reaction (Real-Time PCR), was used to quantify the expression of PDX-1 and NGN-3.
Detailed description
Pregnant women attended in the Maternal-Fetal Medicine Service of the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, were invited to participate. Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition were excluded and those with incomplete clinical files were discarded from the final analysis. Two groups were integrated: a) patients with a healthy gestation and b) patients with GDM.
From all patients the next information was captured in an excell sheet: weight, height, Body Mass Index, blood pressure, albumin, creatinine, electrolytes, glucose, total cholesterol, triglycerides, transaminases and relative expression of PDX-1 and NGN-3.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Women with normoevolutionary gestation. |
| Problem group | – | –Patients with GDM. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women attended in the Maternal-Fetal Medicine Service of the HMPMP.
Key inclusion criteria (1 listed)
- Pregnant women older than 18 years old.
Key exclusion criteria (1 listed)
- Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition.
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
ARNm expression
Time frame: Nine months
Expression of the genes PDX-1 and NGN-3
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 28 May 2019.
- Background: PubMed 28921917Sandikci M, Karagenc L, Yildiz M. Changes on the Pancreas in Experimental Diabetes and the Effect of Lycopene on These Changes: Pdx-1, Ngn-3, and Nestin Expressions. Anat Rec (Hoboken). 2017 Dec;300(12):2200-2207. doi: 10.1002/ar.23687. Epub 2017 Sep 26.
- Background: PubMed 11973276Gu G, Dubauskaite J, Melton DA. Direct evidence for the pancreatic lineage: NGN3+ cells are islet progenitors and are distinct from duct progenitors. Development. 2002 May;129(10):2447-57. doi: 10.1242/dev.129.10.2447.
- Results publication: PubMed 29730292Wang L, Fan H, Zhou L, Wu Y, Lu H, Luo J. Altered expression of PGC-1alpha and PDX1 and their methylation status are associated with fetal glucose metabolism in gestational diabetes mellitus. Biochem Biophys Res Commun. 2018 Jun 18;501(1):300-306. doi: 10.1016/j.bbrc.2018.05.010. Epub 2018 May 7.
- Results publication: PubMed 30373146Plows JF, Stanley JL, Baker PN, Reynolds CM, Vickers MH. The Pathophysiology of Gestational Diabetes Mellitus. Int J Mol Sci. 2018 Oct 26;19(11):3342. doi: 10.3390/ijms19113342.
- Individual participant dataSharing planned: Undecided. Information will be available upon request.
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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.
Hugo Mendieta Zerón, PhD. principal investigator
Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
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, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
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 1 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 28 May 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 Mexico. 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?
ARNm expression (time frame: Nine months). 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 NCT03964987, which also lists 4 linked publications.
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 28 May 2019.