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Autonomic Nervous System and Exercise In Gestational Diabetes

NCT01675271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-11-05

No results posted yet for this study

Summary

The focus of this study is on individualized exercise prescription on primary prevention of cardiovascular diseases (CVD). Special attention is set on autonomic nervous system function and inflammation.

This study will seek novel, cost-effective models of exercise prescription that will emphasize individuals own response on her health and which would be easily implemented to primary health care as primary prevention for CVD. According to power calculation,sixty women planning pregnancy with BMI equal or over 30 and/or history of GDM will be recruited and randomized to an individual exercise arm (n=20), a general exercise arm (n=20) and a control arm (n=20). General intervention group will receive general exercise and dietary counselling whereas a personal exercise and dietary programs will be planned for individualized exercise group. Those randomized to the control arm will receive no dietary and exercise information.

Clinical exercise tests and autonomic nervous system tests will be performed in the beginning of the study and after 3 months intervention. Blood samples for markers of inflammation, glucose homeostasis and lipid status will be collected from prepregnancy period until 1 years after delivery.

Conditions

  • Gestational Diabetes
  • Cardiovascular Risk Factors

Interventions

OTHER

individual exercise

individual exercise and dietary prescription

OTHER

general exercise

general exercise counselling

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Aila Tiitinen, professor · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-09-30
Completion
2016-01-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675271 on ClinicalTrials.gov