Exercise Intervention to Prevent Gestational Diabetes

NCT02304718 | Completed

• 1 other identifier: 400010558
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the role of exercise intervention in reducing the risk of gestational diabetes mellitus(GDM) risk of overweight/obese(prepregnancy BMI≥24kg/m\^2） Chinese pregnant women. Half of participants will have exercise intervention, while the other half will not. Both of the two group will have regular prenatal care.

Conditions

Gestational Diabetes Mellitus

Keywords

GDM; pregnancy outcome; obesity; exercise; overweight

Outcome Measures

Primary Outcomes (1)

• the risk of gestational diabetes mellitus

  GDM will be diagnosed by an oral glucose tolerance test (OGTT) according to the new World Health Organization criteria as fasting glucose level in fasting whole blood 5.1 mmol/L or more, or 2-hour value 8.5mmol/L or more.Then we can use the rate of GDM ocurrence to represent the risk of gestational diabetes mellitus

  up to 24-28 gestational weeks

Secondary Outcomes (5)

• weight gain

  up to 42 gestatioanl weeks

• insulin resistance

  up to 13, 26 and 39 gestatioanl weeks

• adipocytes

  up to 13, 26 and 39 gestatioanl weeks

• inflammatory factor

  up to 13, 26 and 39 gestatioanl weeks

• pregnancy outcome

  up to 42 gestational weeks

Study Arms (2)

exercise intervention group

EXPERIMENTAL

Pregnant women randomised to the exercise intervention group will complete three supervised, exercise sessions each week, exercise sessions completed on alternate days, and lasts until they give birth by using a stational bike. And also they will have regular prenatal care.

Behavioral: Stationary bike

control group

NO INTERVENTION

Pregnant women randomised to the control group only have regular prenatal care.

Interventions

Stationary bike BEHAVIORAL

exercise intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese overweight/obese(prepregnancy BMI≥24kg/m\^2) pregnant women aged between 18 years and 45 years with a singleton live fetus.

You may not qualify if:

• High-risk pregnancies or diseases that could interfere with participation (or both), such as heart insufficiency, infectious diseases, cervical incompetence, multiple pregnancy,serious blood diseases, serious hypertension,absence of prenatal control, risk of premature labour.
• Prepregnant type 1 or 2 diabetes mellitus.
• Impaired glucose trolerance (IGT) and impaired fasting glucose(IFG)

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (8)

• Halse RE, Wallman KE, Newnham JP, Guelfi KJ. Home-based exercise training improves capillary glucose profile in women with gestational diabetes. Med Sci Sports Exerc. 2014 Sep;46(9):1702-9. doi: 10.1249/MSS.0000000000000302.

  PMID: 24518194 BACKGROUND

• Yin YN, Li XL, Tao TJ, Luo BR, Liao SJ. Physical activity during pregnancy and the risk of gestational diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2014 Feb;48(4):290-5. doi: 10.1136/bjsports-2013-092596. Epub 2013 Sep 13.

  PMID: 24037671 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

• Kaar JL, Crume T, Brinton JT, Bischoff KJ, McDuffie R, Dabelea D. Maternal obesity, gestational weight gain, and offspring adiposity: the exploring perinatal outcomes among children study. J Pediatr. 2014 Sep;165(3):509-15. doi: 10.1016/j.jpeds.2014.05.050. Epub 2014 Jul 1.

  PMID: 24996985 BACKGROUND

• Singh J, Huang CC, Driggers RW, Timofeev J, Amini D, Landy HJ, Miodovnik M, Umans JG. The impact of pre-pregnancy body mass index on the risk of gestational diabetes. J Matern Fetal Neonatal Med. 2012 Jan;25(1):5-10. doi: 10.3109/14767058.2012.626920. Epub 2011 Nov 9.

  PMID: 21955004 BACKGROUND

• You T, Arsenis NC, Disanzo BL, Lamonte MJ. Effects of exercise training on chronic inflammation in obesity : current evidence and potential mechanisms. Sports Med. 2013 Apr;43(4):243-56. doi: 10.1007/s40279-013-0023-3.

  PMID: 23494259 BACKGROUND

• Golbidi S, Laher I. Exercise induced adipokine changes and the metabolic syndrome. J Diabetes Res. 2014;2014:726861. doi: 10.1155/2014/726861. Epub 2014 Jan 19.

  PMID: 24563869 BACKGROUND

• Wang C, Wei Y, Zhang X, Zhang Y, Xu Q, Su S, Zhang L, Liu C, Feng Y, Shou C, Guelfi KJ, Newnham JP, Yang H. Effect of Regular Exercise Commenced in Early Pregnancy on the Incidence of Gestational Diabetes Mellitus in Overweight and Obese Pregnant Women: A Randomized Controlled Trial. Diabetes Care. 2016 Oct;39(10):e163-4. doi: 10.2337/dc16-1320. No abstract available.

  PMID: 27660125 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Obesity; Motor Activity; Overweight

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; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Yu-mei Wei, MD

  Mrs

  PRINCIPAL INVESTIGATOR

• Chen Wang, PhD

  Ms

  PRINCIPAL INVESTIGATOR

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: Ms

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 2, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

CN (1)