Gestational Diabetes MellitusNCT01274052
Study of Postprandial Incretin Response in Women With Gestational Diabetes
An observational study of Gestational Diabetes Mellitus, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Meal test
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Jul 2008
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Healthy pregnant woman were examined with a 75 g oral glucose tolerance test. Subjects with plasma glucose (PG) values at 120 min >9.0 mmol/l were diagnosed with gestational diabetes and subjects with PG <9.0 mmol/l were enrolled as healthy controls.
Who may be able to join
- Normal haemoblobin
- Willingness to participate
Who cannot join
- First degree relative with diabetes
- Diabetes before pregnancy
- Positive islet cell- and GAD-65 autoantibodies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine, Glostrup Hospital
Glostrup Municipality, 2600
About this study
Official title: Reduced Postprandial GLP-1 Response in Gestational Diabetes Mellitus: a Fully Reversible Phenomenon
The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.
The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.
Read the detailed description
The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.
The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Meal test
- Keywords
- Gestational diabetes mellitus, Meal test, Incretin hormones, Glucagon-like peptide-1 (GLP-1), Glucose-dependent insulinotropic polypeptide, Insulin, C-peptide, Glucagon
- 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.
Meal testOther
Liquid meal test
| Study group | Role | What they receive |
|---|---|---|
| Gestational Diabetes Mellitus | Women with Gestational Diabetes Mellitus Receives: Other: Meal test | |
| Normal Glucose Tolerance | Women with Normal Glucose Tolerance Receives: Other: Meal test |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Diabetes Association, Aase and Ejnar Danielsens Foundation, The Novo Nordic Foundation
- Investigators
- Filip K Knop, MD PhD, Principal investigator, Diabetes Research Division, Gentofte Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274052
- Sponsor's protocol ID
- KA-060015
- Status last verified
- Jan 2011
- First submitted
- 10 Jan 2011
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hare KJ, Bonde L, Svare JA, Randeva HS, Asmar M, Larsen S, Vilsboll T, Knop FK. Decreased plasma chemerin levels in women with gestational diabetes mellitus. Diabet Med. 2014 Aug;31(8):936-40. doi: 10.1111/dme.12436. Epub 2014 Apr 1.
PubMed 24628007
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Postprandial GLP-1 Response in Gestational Diabetes Mellitus: a Fully Reversible Phenomenon
- ClinicalTrials.gov ID
- NCT01274052
- Acronym / sponsor ID
- KA-060015
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational diabetes mellitus, Meal test, Incretin hormones, Glucagon-like peptide-1 (GLP-1), Glucose-dependent insulinotropic polypeptide, Insulin, C-peptide, Glucagon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Diabetes Association, Aase and Ejnar Danielsens Foundation, The Novo Nordic Foundation
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Jan 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 researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.
The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.
Detailed description
The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.
The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational Diabetes Mellitus | – | Other: Meal testWomen with Gestational Diabetes Mellitus |
| Normal Glucose Tolerance | – | Other: Meal testWomen with Normal Glucose Tolerance |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy pregnant woman were examined with a 75 g oral glucose tolerance test. Subjects with plasma glucose (PG) values at 120 min >9.0 mmol/l were diagnosed with gestational diabetes and subjects with PG <9.0 mmol/l were enrolled as healthy controls.
Key inclusion criteria (2 listed)
- Normal haemoblobin
- Willingness to participate
Key exclusion criteria (3 listed)
- First degree relative with diabetes
- Diabetes before pregnancy
- Positive islet cell- and GAD-65 autoantibodies
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 |
|---|---|---|
| Meal testLiquid meal test | Other | Gestational Diabetes Mellitus, Normal Glucose Tolerance |
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 11 Jan 2011.
- Derived from this study: PubMed 24628007Hare KJ, Bonde L, Svare JA, Randeva HS, Asmar M, Larsen S, Vilsboll T, Knop FK. Decreased plasma chemerin levels in women with gestational diabetes mellitus. Diabet Med. 2014 Aug;31(8):936-40. doi: 10.1111/dme.12436. Epub 2014 Apr 1.
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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.
Filip K Knop, MD PhD principal investigator
Diabetes Research Division, Gentofte Hopsital
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 University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 3 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 11 Jan 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 Denmark. 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?
On the ClinicalTrials.gov record for NCT01274052, which also lists 1 linked publication.
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 11 Jan 2011.