Autonomic Nervous System and Exercise In Gestational Diabetes

NCT01675271 | Completed

• 1 other identifier: 300/E9/06
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gestational diabetes; inflammation; autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• VO2max

  after 3 months training

Secondary Outcomes (4)

• Heart rate variability

  6 weeks postpartum

• autonomic nervous system function

  after 3 months training

• quality of life

  1 year after delivery

• mental health

  1 year after delivery

Study Arms (3)

individual exercise

ACTIVE COMPARATOR

individualized exercise program

Other: individual exercise

general exercise

ACTIVE COMPARATOR

general exercise program

Other: general exercise

control

NO INTERVENTION

No exercise and dietary counselling

Interventions

individual exercise OTHER

individual exercise and dietary prescription

individual exercise

general exercise OTHER

general exercise counselling

general exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital / dept of Obstetrics and Gynecology

Helsinki, 00029, Finland

Location

Related Publications (6)

• 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.

  PMID: 19465232 BACKGROUND

• 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.

  PMID: 16936156 BACKGROUND

• 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.

  PMID: 17762377 BACKGROUND

• 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.

  PMID: 20876206 BACKGROUND

• 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.

  PMID: 20722671 BACKGROUND

• 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.

  PMID: 21309051 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Inflammation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aila Tiitinen, professor

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: August 29, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

FI (1)