InflammationPhase 1NCT00311064
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight
A Phase 1 study testing physical activity in people with Inflammation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Purpose: The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. 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
- Inflammation
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Jan 2008
- Phase
- Phase 1
- 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
Who may be able to join
- BMI > 30 kg/m2
- BMI < 45 kg/m2
- Healthy
- Over 18 years of age
- No earlier preterm delivery (before 37)
- Singleton pregnancy
- 14 weeks +/- 1 week of gestation
Who cannot join
- BMI > 45 kg/m2
- Earlier preterm delivery (before 37)
- Not singleton pregnancy
- Medically treated diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Obstetric Clinic, Juliane Marie Centret
Copenhagen, Østerbro, 2100
About this study
Official title: Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity
Purpose:
The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.
Read the detailed description
Material and Method:
This study falls in two fields:
First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated.
280 overweight (body mass index [BMI] > 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly.
Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.
- Conditions
- Inflammation
- Being tested
- physical activity
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
perinatal mortality
congenital malformations and preeclampsia
gestational hypertension and gestational diabetes mellitus (GDM)
preterm delivery
too large infants (> 2 standard deviation [SD])
Secondary outcomes (2)
delivery by caesarian section
induction of labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMar 2006
- Study completionJan 2008 (estimated)
Why it stopped: because of lack of funding and recruitment problems the study has been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Bettina Breitowicz, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311064
- Sponsor's protocol ID
- 01 285157
- Status last verified
- Aug 2007
- First submitted
- 4 Apr 2006
- Last updated
- 21 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Only Overweight. The Influence of Physical Activity
- ClinicalTrials.gov ID
- NCT00311064
- Acronym / sponsor ID
- 01 285157
- Conditions
- Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: because of lack of funding and recruitment problems the study has been closed.
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jan 2008 (estimated)
- First posted
- 5 Apr 2006 (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.
Purpose:
The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.
Detailed description
Material and Method:
This study falls in two fields:
First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated.
280 overweight (body mass index [BMI] > 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly.
Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI > 30 kg/m2
- BMI < 45 kg/m2
- Healthy
- Over 18 years of age
- No earlier preterm delivery (before 37)
Key exclusion criteria (4 listed)
- BMI > 45 kg/m2
- Earlier preterm delivery (before 37)
- Not singleton pregnancy
- Medically treated diseases
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 |
|---|---|---|
| physical activity | Behavioural | – |
Primary outcome
perinatal mortality
congenital malformations and preeclampsia
gestational hypertension and gestational diabetes mellitus (GDM)
preterm delivery
too large infants (> 2 standard deviation [SD])
2 secondary outcomes
delivery by caesarian section
induction of labour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2007.
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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.
Bettina Breitowicz, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing physical activity in people with Inflammation, run by Copenhagen University Hospital, Rigshospitalet 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 7 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: withdrawn, as of the sponsor's last update on 21 Aug 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
perinatal mortality. The study lists 5 primary outcomes in all. 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 21 Aug 2007.