Exercise in Pregnant Women With Gestational Diabetes

NCT ID: NCT04145479

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

all women with diet and lifestyle controlled gestational diabetes. each will serve as their own control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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low-resistance

women will perform low-resistance physical activity

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

exercise

aerobic

women will perform aerobic physical activity

Group Type EXPERIMENTAL

physical activity

Intervention Type BEHAVIORAL

exercise

Interventions

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physical activity

exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Amy Miyoshi Valent

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy M Valent, DO

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy M Valent, DO

Role: CONTACT

5035027220

Michaela Rickert, PA

Role: CONTACT

Facility Contacts

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Amy M Valent, DO

Role: primary

503-502-7220

Other Identifiers

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20116

Identifier Type: -

Identifier Source: org_study_id

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