Glucose and Blood Pressure During Pregnancy

Blood Pressure Clinical Trial

Official title:

Predictive Role of Non-Invasive Glucose Assessment During Pregnancy: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04979312
• Other study ID #: 21-000284
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Madeline S Reid
• Phone: 507-255-0007
• Email: Reid.Madeline[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to examine the beneficial effects of regular, non-invasive, glucose (sugar) assessment on glucose (sugar) and blood pressure regulation during pregnancy to help in predicting gestational diabetes and preeclampsia.

Description:

This is an open-label pilot trial for the LabClasp combined with standard clinical care compared to standard clinical on [glucose] and blood pressure during pregnancy. Potential study participants will be pre-screened using questionnaires and review of their clinical records. Once the consent has been obtained, participants will undergo screening to confirm eligibility. Subjects who meet all criteria will be randomized to either LC+SC or SC cohorts for 24-39wks depending upon their gestational duration at enrollment. Study measures including anthropometrics, surveys/questionnaires, 24hr ABPM, accelerometry, and an oral glucose tolerance test (OGTT). Furthermore, the investigators will obtain repeated (annual) subject information including vitals, labs, medications, and development of cardiometabolic disorders for up to 10yrs in follow-up by reviewing Mayo Clinic medical records.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• • Age range: 18-45 years (inclusive)
• Body mass index (BMI) =40kg/m2
• >1 risk factor for GDM
• <16wks gestation
• Gender: only females will be recruited into this study
• Target disease or condition: pregnancy
• Individuals with treated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the study
• Ability to provide written informed consent

Exclusion Criteria:

• • Presence of chronic kidney disease (creatinine >2.5mg/dL) and/or active cancer
• Smoking
• Multiple pregnancies
• Congenital abnormalities
• Use of chronic medications which influence blood [glucose] or [insulin]
• Subsequent diagnosis of GDM

Related Conditions & MeSH terms

• Blood Pressure
• Diabetes, Gestational
• Eclampsia
• Gestational Diabetes
• Pre-Eclampsia

Intervention

Device:
• LabClasp
participants will be randomized to LabClasp + standard care or just standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of gestational diabetes mellitus and preeclampsia	measuring glucose non-invasively will prevent gestational diabetes mellitus and preeclampsia during pregnancy	24-39 weeks
Secondary	Examine role of sleep as a potential mechanism in changing blood glucose in pregnancy	measuring glucose non-invasively may aid in sleep, thereby improving blood glucose	24-39 weeks
Secondary	Examine role of sleep as a potential mechanism in changing blood pressure in pregnancy	measuring glucose non-invasively may aid in sleep, thereby improving blood pressure	24-39 weeks

External Links

•   Mayo Clinic Clinical Trials