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Gestational DiabetesANS-EXENCT01675271

Autonomic Nervous System and Exercise In Gestational Diabetes

A study testing individual exercise and general exercise in people with Gestational Diabetes and Cardiovascular Risk Factors, run by Helsinki University Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
individual exercise and general exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFinland
Study dates
Feb 2012to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • diagnosed diabetes
  • smoking
  • user of peroral glucocorticoids
  • user of SSRI medication
  • physical or psychological disability
  • significant co-operation difficulties (e.g. insufficient language skills)

Trial locations and contacts

1 site in 1 country.

Finland1 site
  • Helsinki University Central Hospital / dept of Obstetrics and Gynecology

    Helsinki, 00029

Other trials in Finland

About this study

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

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.

Read the 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.

Being tested
individual exercise, general exercise
Keywords
gestational diabetes, inflammation, autonomic nervous system
Medical subject headings
Diabetes, Gestational, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • individual exerciseOther

    individual exercise and dietary prescription

  • general exerciseOther

    general exercise counselling

Study groups in NCT01675271
Study groupRoleWhat they receive
individual exerciseActive comparatorindividualized exercise program
Receives: Other: individual exercise
general exerciseActive comparatorgeneral exercise program
Receives: Other: general exercise
controlNo interventionNo exercise and dietary counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2max

    Measured: after 3 months training

Secondary outcomes (4)
  1. Heart rate variability

    Measured: 6 weeks postpartum

  2. autonomic nervous system function

    heart rate variability, baroreflex sensitivity, handgrip test

    Measured: after 3 months training

  3. quality of life

    15D questionnaire

    Measured: 1 year after delivery

  4. mental health

    EDPS questionnaire

    Measured: 1 year after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01675271
Sponsor's protocol ID
300/E9/06
Acronym
ANS-EXE
Status last verified
Nov 2018
First submitted
17 Jun 2012
Last updated
5 Nov 2018
Results posted
No
Data monitoring committee
No

Publications

  • Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.

    PubMed 19465232
  • Carr DB, Utzschneider KM, Hull RL, Tong J, Wallace TM, Kodama K, Shofer JB, Heckbert SR, Boyko EJ, Fujimoto WY, Kahn SE. Gestational diabetes mellitus increases the risk of cardiovascular disease in women with a family history of type 2 diabetes. Diabetes Care. 2006 Sep;29(9):2078-83. doi: 10.2337/dc05-2482.

    PubMed 16936156
  • Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.

    PubMed 17762377
  • Tobias DK, Zhang C, van Dam RM, Bowers K, Hu FB. Physical activity before and during pregnancy and risk of gestational diabetes mellitus: a meta-analysis. Diabetes Care. 2011 Jan;34(1):223-9. doi: 10.2337/dc10-1368. Epub 2010 Sep 27.

    PubMed 20876206
  • Poyhonen-Alho M, Viitasalo M, Nicholls MG, Lindstrom BM, Vaananen H, Kaaja R. Imbalance of the autonomic nervous system at night in women with gestational diabetes. Diabet Med. 2010 Sep;27(9):988-94. doi: 10.1111/j.1464-5491.2010.03062.x.

    PubMed 20722671
  • Poyhonen-Alho M, Ebeling P, Saarinen A, Kaaja R. Decreased variation of inflammatory markers in gestational diabetes. Diabetes Metab Res Rev. 2011 Mar;27(3):269-76. doi: 10.1002/dmrr.1170.

    PubMed 21309051

Questions about this trial

What is this clinical trial studying?

A study testing individual exercise and general exercise in people with Gestational Diabetes and Cardiovascular Risk Factors, run by Helsinki University Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2max (time frame: after 3 months training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01675271, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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