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

This study is currently recruiting participants.
Verified August 2012 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Maritta Poyhonen-Alho, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01675271
First received: June 17, 2012
Last updated: August 26, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Gestational Diabetes
Cardiovascular Risk Factors
Other: individual exercise
Other: general exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect Of Individual Exercise Prescription On Cardiovascular Risk Factors In Woman At Risk For Gestational Diabetes - Focus On Autonomic Nervous System And Inflammation

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Heart Rate Variability [ Time Frame: Change from Baseline in Third Trimester of Pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VO2max [ Time Frame: after 3 months training ] [ Designated as safety issue: No ]
  • autonomic nervous system function [ Time Frame: after 3 months training ] [ Designated as safety issue: No ]
    heart rate variability, baroreflex sensitivity, handgrip test

  • quality of life [ Time Frame: 1 year after delivery ] [ Designated as safety issue: No ]
    15D questionnaire

  • mental health [ Time Frame: 1 year after delivery ] [ Designated as safety issue: No ]
    EDPS questionnaire


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: individual exercise
individualized exercise program
Other: individual exercise
individual exercise and dietary prescription
Active Comparator: general exercise
general exercise program
Other: general exercise
general exercise counselling
No Intervention: control
No exercise and dietary counselling

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675271

Contacts
Contact: Maritta Poyhonen-Alho, PhD +358 50 4284690 maritta.poyhonen-alho@hus.fi
Contact: Kristiina Rono, MD +358 9 4711 kristiina.rono@hus.fi

Locations
Finland
Helsinki University Central Hospital / dept of Obstetrics and Gynecology Recruiting
Helsinki, Finland, 00029
Contact: Maritta Poyhonen-Alho, PhD    +358 50 4284690    maritta.poyhonen-alho@hus.fi   
Contact: kristiina rono, MD    +358 9 4711    kristiina.rono@hus.fi   
Principal Investigator: Aila Tiitinen, professor         
Sub-Investigator: Maritta Poyhonen-Alho, PhD         
Sub-Investigator: Kristiina Rono, MD         
Sub-Investigator: Heikki Tikkanen, PhD         
Sub-Investigator: Juha Peltonen, PhD         
Sub-Investigator: Harriet Hagglund, MsC         
Sub-Investigator: Anne Koponen, BSc         
Sub-Investigator: Jyrki Aho, BSc         
Sub-Investigator: Saila Koivusalo, PhD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Aila Tiitinen, professor Helsinki University Central Hospital
  More Information

Publications:
Responsible Party: Maritta Poyhonen-Alho, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01675271     History of Changes
Other Study ID Numbers: 300/E9/06
Study First Received: June 17, 2012
Last Updated: August 26, 2012
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University Central Hospital:
gestational diabetes
inflammation
autonomic nervous system

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

ClinicalTrials.gov processed this record on April 23, 2014