Autonomic Nervous Activity in Women With Gestational Diabetes

NCT00867022 | Completed

• 1 other identifier: GESTSYMPIS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Gestational Diabetes

Keywords

Inflammatory factors; Coagulation factors; Sympathetic activity

Outcome Measures

Primary Outcomes (1)

• Serum Noradrenalin level

Secondary Outcomes (1)

• Heart rate variability: LF, VLF, HF

Study Arms (4)

1

Women with gestational diabetes

2

Pregnant women without gestational daibetes

3

Women with gestational diabetes and hypertension

4

Non pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Department of Obstet and Gyn, Helsinki University Hospital

Helsinki, Uusimaa, 00290, Finland

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: August 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2009
• Last Updated: March 23, 2009

Record last verified: 2009-03

Locations

FI (1)