CClinicalTrials.gg
Status unknownNCT04145479Updated Apr 29, 2022

Exercise in Pregnant Women With Gestational Diabetes

An interventional study of physical activity in Gestational Diabetes, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-04-29.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gestational Diabetes

Keywords

  • gestational diabetes
  • pregnancy
  • exercise
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 12 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    low-resistance

    women will perform low-resistance physical activity

    Behavioral: physical activity

  • Experimental
    aerobic

    women will perform aerobic physical activity

    Behavioral: physical activity

Interventions

  • Behavioralphysical activity

    exercise

06

What researchers measure

Primary outcomes

  1. postprandial glucose

    glucose measure after meal following exercise compared to no exercise

    Time frame: 2 hours after meal

  2. postprandial triglyceride

    triglyceride measure after meal following exercise compared to no exercise

    Time frame: 2 hours after meal

07

Study locations

1 of 1 sites recruiting
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    • Amy M Valent, DO · Contact · valent@ohsu.edu · 503-502-7220
    • Amy M Valent, DO · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04145479
Lead sponsor
Oregon Health and Science University
Responsible party
Amy Miyoshi Valent (Assistant Professor, Oregon Health and Science University) — Principal investigator
First posted
Oct 30, 2019
Start date
Mar 1, 2021
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Apr 29, 2022

Study contacts

Amy M Valent, DO
Contact
valent@ohsu.edu
5035027220
Michaela Rickert, PA
Contact
covelli@ohsu.edu
Amy M Valent, DO
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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