Gestational DiabetesNCT01307995
The Incretin Effect in Patients With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2007to May 2010
- 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
- Healthy volunteers accepted
- Adult
Study population: Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)
Who may be able to join
- age above 18 years old
- GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)
Who cannot join
- Previous diagnosis of DM
- Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
- Affected biochemical liver parameters (ALAT > 2 times normal upper range)
- Affected biochemical kidney parameters (se-creatinine > 130 µM)
- Treatment with medicine interacting with insulin secretion (e.g. steroids)
- Treatment with medicine that can not be paused for 16 hours
Trial locations and contacts
1 site in 1 country.
Poland1 site
Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital
Lodz, 93-338
About this study
Official title: Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.
The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.
- Conditions
- Gestational Diabetes
- Keywords
- GDM, incretin effect, gestation, reversibility
- 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 |
|---|---|---|
| GDM | Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT | |
| NGT | Pregnant patients with normal glucose tolerance as observed in 75g OGTT |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startApr 2007
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Investigators
- Katarzyna Cypryk, MD, PhD, Asoc. Prof., Study director, Medical University LodzTina Vilsbøll, MD, DMSc, Study director, University of CopenhagenMarcin Kosiński, MD, PhD, Principal investigator, Medical University Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307995
- Sponsor's protocol ID
- GDM-INK
- Status last verified
- Jan 2011
- First submitted
- 2 Mar 2011
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.
- ClinicalTrials.gov ID
- NCT01307995
- Acronym / sponsor ID
- GDM-INK
- Conditions
- Gestational Diabetes
- Keywords
- GDM, incretin effect, gestation, reversibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Apr 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Mar 2011 (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.
The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.
Study design
- Observational model
- Case crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM | – | –Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT |
| NGT | – | –Pregnant patients with normal glucose tolerance as observed in 75g OGTT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)
Key inclusion criteria (2 listed)
- age above 18 years old
- GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)
Key exclusion criteria (6 listed)
- Previous diagnosis of DM
- Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
- Affected biochemical liver parameters (ALAT > 2 times normal upper range)
- Affected biochemical kidney parameters (se-creatinine > 130 µM)
- Treatment with medicine interacting with insulin secretion (e.g. steroids)
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
Not reported in the source record.
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 3 Mar 2011.
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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.
Katarzyna Cypryk, MD, PhD, Asoc. Prof. study director
Medical University Lodz
Tina Vilsbøll, MD, DMSc study director
University of Copenhagen
Marcin Kosiński, MD, PhD principal investigator
Medical University Lodz
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 Medical University of Lodz at 1 site in Poland.
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 2 inclusion and 6 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 3 Mar 2011. 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 Poland. 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.
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 3 Mar 2011.