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Autonomic Nervous Activity in Women With Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT00867022
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : March 23, 2009
Sponsor:
Information provided by:
Helsinki University

Brief 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. 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

Condition or disease
Gestational Diabetes

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Autonomic Nervous Activity in Women With Gestational Diabetes
Study Start Date : August 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Women with gestational diabetes
2
Pregnant women without gestational daibetes
3
Women with gestational diabetes and hypertension
4
Non pregnant women



Primary Outcome Measures :
  1. Serum Noradrenalin level

Secondary Outcome Measures :
  1. Heart rate variability: LF, VLF, HF


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Clinical diagnosis of gestational diabetes (OGTT) with or without BP > 140/90.
  • Pregnant control with normal OGTT-

Exclusion Criteria:

  • Smoking
  • Uncontrolled hypertension
  • Diabetes
  • Medication affecting sympathetic activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867022


Locations
Finland
Department of Obstet and Gyn, Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00290
Sponsors and Collaborators
Helsinki University

Responsible Party: Risto Kaaja, Helsinki University Hospital
ClinicalTrials.gov Identifier: NCT00867022     History of Changes
Other Study ID Numbers: GESTSYMPIS
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: March 23, 2009
Last Verified: March 2009

Keywords provided by Helsinki University:
Inflammatory factors
Coagulation factors
Sympathetic activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications