Exercise in Pregnant Women With Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Evaluating the Effects of Low-resistance and Aerobic Exercise on Glucose and Lipids in Pregnant Women With Gestational Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145479
• Other study ID #: 20116
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Oregon Health and Science University
• Contact: Amy M Valent, DO
• Phone: 5035027220
• Email: valent[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gestational diabetes (GDM) impacts 1 in 10 pregnancies; hyperglycemia and hypertriglyceridemia are common features of the condition. Women are recommended to do at least 150 minutes of moderate-intensity aerobic activity a week during pregnancy and the postpartum period. Exercise both during and out of pregnancy has been shown to be an effective non-pharmacologic tool to reduce glucose and lipid profiles. The goals and purpose of this pilot study is to 1) determine the influence of exercise and the timing of exercise surrounding a meal on glucose and lipid metabolism in pregnant women with GDM and 2) determine the feasibility of low-resistance and aerobic activity and measuring exercise metrics during pregnancy. The overarching objective of this study is to determine the effects of low-resistance and aerobic exercise on glucose and lipids following a meal in pregnant women with GDM.

Description:

Gestational diabetes (GDM) impacts 1 in 10 pregnancies; hyperglycemia and hypertriglyceridemia are common features of the condition. Women are recommended to do at least 150 minutes of moderate-intensity aerobic activity a week during pregnancy and the postpartum period. Exercise both during and out of pregnancy has been shown to be an effective non-pharmacologic tool to reduce glucose and lipid profiles. The goals and purpose of this pilot study is to 1) determine the influence of exercise and the timing of exercise surrounding a meal on glucose and lipid metabolism in pregnant women with GDM and 2) determine the feasibility of low-resistance and aerobic activity and measuring exercise metrics during pregnancy. The overarching objective of this study is to determine the effects of low-resistance and aerobic exercise on glucose and lipids following a meal in pregnant women with GDM. Women will perform either low-resistance or aerobic exercise. Blood will be taken before and 2 hours after a fixed meal. For safety, women will have supervised exercise and oxygen consumption will be measured throughout the activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• diet and lifestyle controlled gestational diabetes

• Gestational age 28 weeks-32 weeks gestation

• Age 18-50 years

• Singleton pregnancy

Exclusion Criteria:

• Chronic hypertension

• Pregestational diabetes

• History of peripartum cardiomyopathy

• Any condition contraindicating for exercise

• Taking any cardiovascular modifying medications (beta-blockers, calcium channel blockers, corticosteroids)

• Asthma or other underlying lung disease that is equivalent or worse than persistent mild classification (defined as at least >2 day/week asthmatic symptoms, 1-2x/month nighttime awakenings, >2days/week short-acting beta-agonist use for symptom control, and minor limitations with normal activity; =2 exacerbations in 6 months requiring oral systemic corticosteroids, =4 wheezing episodes/1 year lasting >1 day)

• Congenital anomalies

• Multifetal gestation

• Current alcohol use

• Current tobacco use

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• physical activity
exercise

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial glucose	glucose measure after meal following exercise compared to no exercise	2 hours after meal
Primary	postprandial triglyceride	triglyceride measure after meal following exercise compared to no exercise	2 hours after meal