Autonomic Nervous Activity in Women With Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Autonomic Nervous Activity in Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867022
• Other study ID #: GESTSYMPIS
• Status: Completed
• Phase: N/A
• First received: March 20, 2009
• Last updated: March 20, 2009
• Start date: August 2004
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
Finland	Department of Obstet and Gyn, Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Noradrenalin level			No
Secondary	Heart rate variability: LF, VLF, HF			No