Glucose Control in Type 2 Diabetes in Pregnancy

Eastern Virginia Medical School (EVMS)

Status: Not yet enrolling

Conditions: Pregestational Diabetes; Type 2 Diabetes

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07250698

24-06-FB-0155

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Management of diabetes outside of study location

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Post-prandial walk

Active Comparator group

Description:

Participants in this arm of the study will be instructed to walk for 20 minutes after each meal (breakfast, lunch, and dinner). They will also be given a continuous glucose monitor and a FitBit, to wear throughout their participation in the study.

Treatment:

Behavioral: Exercise

Standard of Care

No Intervention group

Description:

Participants in this arm will be given the regular counseling on the importance of exercise during pregnancy, but not instructed to walk after each meal. They will receive a continuous glucose monitor and FitBit to wear throughout their participation in the study.