Exercise in Pregnant Women With Gestational Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: physical activity

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy M Valent, DO; Phone Number: 5035027220; Email: valent@ohsu.edu
• Study Contact Backup: Name: Michaela Rickert, PA; Email: covelli@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
      • Contact: Amy M Valent, DO; Phone Number: 503-502-7220; Email: valent@ohsu.edu
      • Principal Investigator: Amy M Valent, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-resistance; women will perform low-resistance physical activity	Behavioral: physical activity; exercise
Experimental: aerobic; women will perform aerobic physical activity	Behavioral: physical activity; exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postprandial glucose	glucose measure after meal following exercise compared to no exercise	2 hours after meal
postprandial triglyceride	triglyceride measure after meal following exercise compared to no exercise	2 hours after meal

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Amy M Valent, DO, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise; pregnancy; gestational diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 20116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: after publication for 1 year
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No