Exercise in Pregnant Women With Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes focused on measuring gestational diabetes, pregnancy, exercise
Eligibility Criteria
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
Sites / Locations
- Oregon Health and Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
low-resistance
aerobic
Arm Description
women will perform low-resistance physical activity
women will perform aerobic physical activity
Outcomes
Primary Outcome Measures
postprandial glucose
glucose measure after meal following exercise compared to no exercise
postprandial triglyceride
triglyceride measure after meal following exercise compared to no exercise
Secondary Outcome Measures
Full Information
NCT ID
NCT04145479
First Posted
October 27, 2019
Last Updated
April 27, 2022
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04145479
Brief Title
Exercise in Pregnant Women With Gestational Diabetes
Official Title
Evaluating the Effects of Low-resistance and Aerobic Exercise on Glucose and Lipids in Pregnant Women With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, pregnancy, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all women with diet and lifestyle controlled gestational diabetes. each will serve as their own control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low-resistance
Arm Type
Experimental
Arm Description
women will perform low-resistance physical activity
Arm Title
aerobic
Arm Type
Experimental
Arm Description
women will perform aerobic physical activity
Intervention Type
Behavioral
Intervention Name(s)
physical activity
Intervention Description
exercise
Primary Outcome Measure Information:
Title
postprandial glucose
Description
glucose measure after meal following exercise compared to no exercise
Time Frame
2 hours after meal
Title
postprandial triglyceride
Description
triglyceride measure after meal following exercise compared to no exercise
Time Frame
2 hours after meal
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy M Valent, DO
Phone
5035027220
Email
valent@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michaela Rickert, PA
Email
covelli@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Valent, DO
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy M Valent, DO
Phone
503-502-7220
Email
valent@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Amy M Valent, DO
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
after publication for 1 year
Learn more about this trial
Exercise in Pregnant Women With Gestational Diabetes
We'll reach out to this number within 24 hrs