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Clinical Trials/NCT04145479
NCT04145479UnknownNot Applicable

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

Oregon Health and Science University1 site in 1 country12 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
12
Locations
1
Primary Endpoint
postprandial glucose

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

low-resistance

Experimental

women will perform low-resistance physical activity

Intervention: physical activity (Behavioral)

aerobic

Experimental

women will perform aerobic physical activity

Intervention: physical activity (Behavioral)

Outcomes

Primary Outcomes

postprandial glucose

Time Frame: 2 hours after meal

glucose measure after meal following exercise compared to no exercise

postprandial triglyceride

Time Frame: 2 hours after meal

triglyceride measure after meal following exercise compared to no exercise

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amy Miyoshi Valent

Assistant Professor

Oregon Health and Science University

Study Sites (1)

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