Clinical trial NCT04145479: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
pregnancy
exercise
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: all women with diet and lifestyle controlled gestational diabetes. each will serve as their own control
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: postprandial glucose
timeFrame: 2 hours after meal
measure: postprandial triglyceride
timeFrame: 2 hours after meal
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Amy M Valent, DO
role: PRINCIPAL_INVESTIGATOR
References: