Diabetes, GestationalNCT03007186
Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus
An observational study of Diabetes, Gestational and Insulin Sensitivity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes, Gestational, Insulin Sensitivity, PreTerm Birth
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2016to Jul 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All participating patients will be pregnant women with a threatening preterm birth admitted to the department of feto-maternal health and obstetrics of the AKH Vienna.
Who may be able to join
- female
- gestational age between 23+0 and 34+6
- an oral glucose tolerance test was made and attests a healthy glucose tolerance (control group) a gestational diabetes mellitus (case group)
- threatening preterm birth
Who cannot join
- missing consent to participate
- age under 18 years
- age over 50 years
- preexistent diabetes (type 1 or 2)
- apparent disease of the thyroid gland
- infectious diseases as HIV or Hepatitis C
- insulin dependent gestational diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Monitoring During Threatening Preterm Birth With Particular Focus on Insulin Sensitivity and Glucose Tolerance in Patients With and Without Gestational Diabetes Mellitus
This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.
Read the detailed description
BACKGROUND:
The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm birth is an long existing part of the obstetric routine procedures. Under this therapy it should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin sensitivity as well as they can cause an impaired maternal glucose tolerance.
Therefore a threatening preterm birth as well as the including medical therapy do challenge the glucose metabolism of mother and child.
Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy, and the numbers are on the rise. GDM is characterized through an insulin resistance during the pregnancy.
High blood glucose level during pregnancy or labour can cause complications like a fetal hypoglycaemia right after birth.
METHODS:
This study includes pregnant women with and without gestational diabetes who are medicated with betamethasone due to threatening preterm birth.
In this study the blood glucose measurements of one week, as well as the measurements of HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy will be considered.
- Conditions
- Diabetes, Gestational, Insulin Sensitivity, PreTerm Birth, Glucose Intolerance During Pregnancy, Glucocorticoids
- Keywords
- Blood glucose monitoring, Glucose tolerance, HbA1C, Insulin, Betamethasone
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance, Premature Birth
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 |
|---|---|---|
| Case group | The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements. | |
| Control group | The oral glucose tolerance test of these women showed no pathological measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose measurements
The patient measures their blood glucose level six times a day for seven days. The times of the measurements are before and one hour after every meal.
Measured: Seven days after betamethasone medication.
Secondary outcomes (3)
HbA1C
HbA1C measurements from a blood draw of the patient.
Measured: One week after the medication with Betamethasone for lung maturation.
Blood Glucose Level
Blood glucose level measurements from a blood draw of the patient.
Measured: One week after the medication with Betamethasone for lung maturation.
Insulin level
Insulin level measurements from a blood draw of the patient.
Measured: One week after the medication with Betamethasone for lung maturation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Linsenmeier, Medical University of Vienna
- Investigators
- Christian Goebl, MD, Study chair, AKH ViennaLara Linsenmeier, Student, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007186
- Sponsor's protocol ID
- 1102/2016
- Status last verified
- Mar 2019
- First submitted
- 19 Dec 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Monitoring During Threatening Preterm Birth With Particular Focus on Insulin Sensitivity and Glucose Tolerance in Patients With and Without Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03007186
- Acronym / sponsor ID
- 1102/2016
- Conditions
- Diabetes, Gestational, Insulin Sensitivity, PreTerm Birth, Glucose Intolerance During Pregnancy, Glucocorticoids
- Keywords
- Blood glucose monitoring, Glucose tolerance, HbA1C, Insulin, Betamethasone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Jan 2017 (estimated)
- 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.
This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.
Detailed description
BACKGROUND:
The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm birth is an long existing part of the obstetric routine procedures. Under this therapy it should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin sensitivity as well as they can cause an impaired maternal glucose tolerance.
Therefore a threatening preterm birth as well as the including medical therapy do challenge the glucose metabolism of mother and child.
Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy, and the numbers are on the rise. GDM is characterized through an insulin resistance during the pregnancy.
High blood glucose level during pregnancy or labour can cause complications like a fetal hypoglycaemia right after birth.
METHODS:
This study includes pregnant women with and without gestational diabetes who are medicated with betamethasone due to threatening preterm birth.
In this study the blood glucose measurements of one week, as well as the measurements of HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy will be considered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements. |
| Control group | – | –The oral glucose tolerance test of these women showed no pathological measurements. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All participating patients will be pregnant women with a threatening preterm birth admitted to the department of feto-maternal health and obstetrics of the AKH Vienna.
Key inclusion criteria (4 listed)
- female
- gestational age between 23+0 and 34+6
- an oral glucose tolerance test was made and attests a healthy glucose tolerance (control group) a gestational diabetes mellitus (case group)
- threatening preterm birth
Key exclusion criteria (7 listed)
- missing consent to participate
- age under 18 years
- age over 50 years
- preexistent diabetes (type 1 or 2)
- apparent disease of the thyroid gland
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
Blood glucose measurements
Time frame: Seven days after betamethasone medication.
The patient measures their blood glucose level six times a day for seven days. The times of the measurements are before and one hour after every meal.
3 secondary outcomes
HbA1C
Time frame: One week after the medication with Betamethasone for lung maturation.
Blood Glucose Level
Time frame: One week after the medication with Betamethasone for lung maturation.
Insulin level
Time frame: One week after the medication with Betamethasone for lung maturation.
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 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Christian Goebl, MD study chair
AKH Vienna
Lara Linsenmeier, Student principal investigator
Medical University of Vienna
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, Gestational and Insulin Sensitivity, run by Medical University of Vienna at 1 site in Austria.
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 4 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 13 Mar 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 Austria. 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?
Blood glucose measurements (time frame: Seven days after betamethasone medication.). 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 13 Mar 2019.