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Gestational Diabetes | Autonomic Nervous System and Exercise In Gestational Diabetes

Gestational Diabetes research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gestational Diabetes

Cardiovascular Risk Factors

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:individual exerciseindividual exercise and dietary prescription

Other:general exercisegeneral exercise counselling

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

individual exerciseindividualized exercise program

general exercisegeneral exercise program

controlNo exercise and dietary counselling

Study Status

Unknown status

Start Date: February 2012

Completed Date: March 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: VO2max

Secondary Outcome: Heart rate variability

Study sponsors, principal investigator, and references

Principal Investigator: Aila Tiitinen, professor

Lead Sponsor: Helsinki University Central Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01675271

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.

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