Recruiting

Exercise

Sponsor:

Oregon Health and Science University

Code:

NCT04145479

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

physical activity

Study Details

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.

Conditions

Gestational Diabetes

Study ID

NCT04145479

Start date

Mar 1, 2021

Status verified date

Apr, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: low-resistance

women will perform low-resistance physical activity

experimental: aerobic

women will perform aerobic physical activity

Interventions

physical activity

exercise

Primary outcome measure

  • postprandial glucose [ Time Frame: 2 hours after meal ]
  • postprandial triglyceride [ Time Frame: 2 hours after meal ]

Central Contacts and Locations

Central contacts

Amy M Valent, DO

5035027220valent@ohsu.edu

Michaela Rickert, PA

covelli@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amy M Valent, DO

503-502-7220valent@ohsu.edu

Principal Investigator:

Amy M Valent, DO

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 29, 2022

Last verified

Apr, 2022

Keywords

  • gestational diabetes
  • pregnancy
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2022-04-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.