NCT04145479

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

October 27, 2019

Last Update Submit

April 27, 2022

Conditions

Gestational Diabetes

Keywords

gestational diabetespregnancyexercise

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

low-resistance

EXPERIMENTAL

women will perform low-resistance physical activity

Behavioral: physical activity

aerobic

EXPERIMENTAL

women will perform aerobic physical activity

Behavioral: physical activity

Interventions

physical activityBEHAVIORAL

exercise

aerobiclow-resistance

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diet and lifestyle controlled gestational diabetes
  • Gestational age 28 weeks-32 weeks gestation
  • Age 18-50 years
  • Singleton pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amy M Valent, DO

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy M Valent, DO

CONTACT

5035027220valent@ohsu.edu

Michaela Rickert, PA

CONTACT

covelli@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: all women with diet and lifestyle controlled gestational diabetes. each will serve as their own control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2019

First Posted

October 30, 2019

Study Start

March 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after publication for 1 year

Locations

US(1)