Glucose Control in Type 2 Diabetes in Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorEastern Virginia Medical School
About this trial
The goal of this clinical trial is to evaluate the effect of physical activity on glucose control in pregnant patients with pregestational Type 2 diabetes. The main question it seeks to answer is "will physical activity following a meal improve blood sugar control in pregnant women with Type 2 diabetes?" Researchers will compare the glucose control of two groups: one that walks for 20 minutes after each meal, and one that does not.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton gestation
Known diagnosis of Type 2 diabetes OR meets new diagnosis of Type 2 diabetes in the first trimester (up to 13 weeks and 6 days)
Age ≥18 and <50 years
Gestational age <32 weeks 0 days gestation
Disqualifiers
Non-English as the primary language
Inability to participate in 20 minutes of walking at a time
Known or suspected fetal anomaly or aneuploidy
Prisoners
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralThis intervention consists of instructions to walk for 20 minutes after each meal.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Post-prandial walkActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Blood Glucose Time in Range
Our primary outcome is the time in range (via CGM data) during the management of Type 2 diabetes in pregnancy between 34 and 36 weeks gestation.
Time frame
Between 34 and 36 weeks gestation.Secondary outcomes
1
Duration of postprandial walk
Duration of postprandial walk (in minutes)
Time frame
From enrollment to delivery, an average of 6 months2
Sleep duration
Amount of time spent sleeping
Time frame
From enrollment to delivery, an average of 6 months3
Baseline heart rate
Heart rate when not exercising
Time frame
From enrollment to delivery, an average of 6 months4
Maximal heart rate during walks
Maximal heart rate during postprandial walks
Time frame
From enrollment to delivery, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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