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Autonomic Nervous Activity in Women With Gestational Diabetes
This study has been completed.
First Received: March 20, 2009   No Changes Posted
Sponsored by: Helsinki University
Information provided by: Helsinki University
ClinicalTrials.gov Identifier: NCT00867022
  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: Case Control, Prospective
Official Title: Autonomic Nervous Activity in Women With Gestational Diabetes

Resource links provided by NLM:


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 ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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

No publications provided

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

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

Study placed in the following topic categories:
Pregnancy Complications
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetes, Gestational
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on August 25, 2009