Gestational DiabetesNCT00867022
Autonomic Nervous Activity in Women With Gestational Diabetes
An observational study of Gestational Diabetes, run by University of Helsinki at 1 site in Finland.
Trial summary
Through complex hormonal pathways, insulin resistance can lead to the activation of the sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients, mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant and non-pregnant women. 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
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2004to Mar 2009
- 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: Gestational diabetic women having or not hypertension with two control groups, one pregnant on non-pregnant. All the women are studied during night time to study the arousal of the sympathetic activity in the early morning hours
Who may be able to join
- Clinical diagnosis of gestational diabetes (OGTT) with or without BP > 140/90.
- Pregnant control with normal OGTT-
Who cannot join
- Smoking
- Uncontrolled hypertension
- Diabetes
- Medication affecting sympathetic activity
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Obstet and Gyn, Helsinki University Hospital
Helsinki, Uusimaa, 00290
About this study
Through complex hormonal pathways, insulin resistance can lead to the activation of the sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients, mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin concentrations also suggest increased sympathetic activity in PE. It has been hypothesized that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic activity, various markers of inflamma-tion are also associated with reduced insulin sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin resistance syndrome. The role of sympathetic over-activity and inflammatory markers in gestational diabetes has not been investigated
- Conditions
- Gestational Diabetes
- Keywords
- Inflammatory factors, Coagulation factors, Sympathetic activity
- 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 |
|---|---|---|
| 1 | Women with gestational diabetes | |
| 2 | Pregnant women without gestational daibetes | |
| 3 | Women with gestational diabetes and hypertension | |
| 4 | Non pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Noradrenalin level
Secondary outcomes (1)
Heart rate variability: LF, VLF, HF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionMar 2009
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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867022
- Sponsor's protocol ID
- GESTSYMPIS
- Status last verified
- Mar 2009
- First submitted
- 20 Mar 2009
- Last updated
- 23 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous Activity in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT00867022
- Acronym / sponsor ID
- GESTSYMPIS
- Conditions
- Gestational Diabetes
- Keywords
- Inflammatory factors, Coagulation factors, Sympathetic activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Mar 2009 (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.
Through complex hormonal pathways, insulin resistance can lead to the activation of the sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients, mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin concentrations also suggest increased sympathetic activity in PE. It has been hypothesized that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic activity, various markers of inflamma-tion are also associated with reduced insulin sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin resistance syndrome. The role of sympathetic over-activity and inflammatory markers in gestational diabetes has not been investigated
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with gestational diabetes |
| 2 | – | –Pregnant women without gestational daibetes |
| 3 | – | –Women with gestational diabetes and hypertension |
| 4 | – | –Non pregnant women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Gestational diabetic women having or not hypertension with two control groups, one pregnant on non-pregnant. All the women are studied during night time to study the arousal of the sympathetic activity in the early morning hours
Key inclusion criteria (2 listed)
- Clinical diagnosis of gestational diabetes (OGTT) with or without BP > 140/90.
- Pregnant control with normal OGTT-
Key exclusion criteria (4 listed)
- Smoking
- Uncontrolled hypertension
- Diabetes
- Medication affecting sympathetic activity
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
Serum Noradrenalin level
1 secondary outcome
Heart rate variability: LF, VLF, HF
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 23 Mar 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Helsinki at 1 site in Finland.
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 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: finished, as of the sponsor's last update on 23 Mar 2009. 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 Finland. 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?
Serum Noradrenalin level. 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 23 Mar 2009.