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Autonomic Nervous System and Exercise In Gestational Diabetes (ANS-EXE)

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ClinicalTrials.gov Identifier: NCT01675271
Recruitment Status : Unknown
Verified March 2015 by Maritta Poyhonen-Alho, Helsinki University Central Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2012
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Maritta Poyhonen-Alho, Helsinki University Central Hospital

June 17, 2012
August 29, 2012
March 23, 2015
February 2012
September 2015   (Final data collection date for primary outcome measure)
VO2max [ Time Frame: after 3 months training ]
Heart Rate Variability [ Time Frame: Change from Baseline in Third Trimester of Pregnancy ]
Complete list of historical versions of study NCT01675271 on ClinicalTrials.gov Archive Site
  • Heart rate variability [ Time Frame: 6 weeks postpartum ]
  • autonomic nervous system function [ Time Frame: after 3 months training ]
    heart rate variability, baroreflex sensitivity, handgrip test
  • quality of life [ Time Frame: 1 year after delivery ]
    15D questionnaire
  • mental health [ Time Frame: 1 year after delivery ]
    EDPS questionnaire
  • VO2max [ Time Frame: after 3 months training ]
  • autonomic nervous system function [ Time Frame: after 3 months training ]
    heart rate variability, baroreflex sensitivity, handgrip test
  • quality of life [ Time Frame: 1 year after delivery ]
    15D questionnaire
  • mental health [ Time Frame: 1 year after delivery ]
    EDPS questionnaire
Not Provided
Not Provided
 
Autonomic Nervous System and Exercise In Gestational Diabetes
Effect Of Individual Exercise Prescription On Cardiovascular Risk Factors In Woman At Risk For Gestational Diabetes - Focus On Autonomic Nervous System And Inflammation

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.

Gestational diabetes (GDM) is one of the earliest signs for increased risk of developing CVD. In addition to this independent association, GDM increases CVD risk through type 2 diabetes. The physiological basis for his disease progression is not yet fully understood. Increasing evidence exists on interplay of insulin resistance and subclinical inflammation, and more recently on unbalance of the autonomic nervous system.

There is unequivocal evidence that increased physical activity and regular exercise can prevent risk factors that give rise to cardiovascular complications. According to a recent meta-analysis, exercise started before and continued throughout pregnancy may lead to marked GDM risk reduction. Unfortunately, exercise in most lifestyle studies is usually unstructured or unsupervised or does not meet current guidelines. There is also a significant gap in our understanding of how to target, deliver and prescribe the beneficial type of exercise to patients at risk in the community.

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. All subjects will be followed by diabetes nurses every 3 months as follows: at the time of recruitment, after 3 months intervention period, int the 1st, 2nd and 3rd trimester of pregnancy and 6 weeks, 6 months and 1 year postpartum. The following measurements will be performed at every visit:blood pressure, weight, waist-to-hip ratio, glucose homeostasis (2-h OGTT, Pf- insulin, Pf- glucose, insulin resistance (Homa-IR), GHbA1c, lipids (total cholesterol, LDL, HDL, triglycerides), inflammatory markers (sCRP,S-amyloid A, IL-1 and 6, alpha 1-glycoprotein, SHBG), adipokines (endothelin, adrenomedullin, adiponectin),dipeptidyl peptidase-4 (DPP-4), atrial natriuretic peptides (ANP, proBNP).For all study participants, 15 D and EDPS questionnaires are used for assessment of quality of life and mental health. Registered costs of the intervention will be calculated for cost-effectiveness analysis.

Both endurance and strength training will be included in the exercise program of the individual exercise study group. Heart rate will be monitored with heart rate belt and registered in internet-based exercise diary which can be instantly followed by the exercise professionals. This information will be used for fine-tuning of their exercise prescription during the intervention period. Diet and weight target will be planned individually by a dietician. Actualized diet will be registered in an internet-based diary instantly followed by the study dietician who will guide the subjects personally by e-mail and suggest further dietary changes if needed.

All subjects will perform an exercise test in the beginning of the study and after 3 months intervention with a step incremental protocol on a cycle ergometer until volitional fatigue. Extensive and advanced technologies will be used to monitor exercise responses, including breath-by-breath ventilation and alveolar gas exchange; exercise ECG; impedance cardiography; automatic arterial blood pressure; analysis system for heart rate variability and blood pressure variability, baroreflex sensitivity, muscle electrical activity, arterial O2 saturation and local cerebral and muscle tissue oxygenation with near-infrared spectroscopy. The autonomic nervous system measurements, including 24 hour ECG monitoring, heart rate variability assessment with controlled breathing rate, the orthostatic test and a 5 min handgrip test, will be performed during another visit to the laboratory. Total haemoglobin mass and blood volume will be determined by carbonmonoxy rebreathing method.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Gestational Diabetes
  • Cardiovascular Risk Factors
  • Other: individual exercise
    individual exercise and dietary prescription
  • Other: general exercise
    general exercise counselling
  • Active Comparator: individual exercise
    individualized exercise program
    Intervention: Other: individual exercise
  • Active Comparator: general exercise
    general exercise program
    Intervention: Other: general exercise
  • No Intervention: control
    No exercise and dietary counselling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
March 2016
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • trying to become pregnant
  • BMI equal or over 30 and/or history of gestational diabetes

Exclusion Criteria:

  • diagnosed diabetes
  • smoking
  • user of peroral glucocorticoids
  • user of SSRI medication
  • physical or psychological disability
  • significant co-operation difficulties (e.g. insufficient language skills)
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01675271
300/E9/06
No
Not Provided
Not Provided
Maritta Poyhonen-Alho, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Study Director: Aila Tiitinen, professor Helsinki University Central Hospital
Helsinki University Central Hospital
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP