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Autonomic Nervous Activity in Women With Gestational Diabetes

This study has been completed.
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00867022
First received: March 20, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Autonomic Nervous Activity in Women With Gestational Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Serum Noradrenalin level [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate variability: LF, VLF, HF [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2004
Study Completion Date: March 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with gestational diabetes
2
Pregnant women without gestational daibetes
3
Women with gestational diabetes and hypertension
4
Non pregnant women

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867022

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

No publications provided

Responsible Party: Risto Kaaja, Helsinki University Hospital
ClinicalTrials.gov Identifier: NCT00867022     History of Changes
Other Study ID Numbers: GESTSYMPIS
Study First Received: March 20, 2009
Last Updated: March 20, 2009
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on May 22, 2013