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Glucose and Blood Pressure During Pregnancy

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04979312
Collaborator
(none)
90
Enrollment
22
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: LabClasp

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Role of Non-Invasive Glucose Assessment During Pregnancy: A Pilot Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Prevention of gestational diabetes mellitus and preeclampsia [24-39 weeks]

    measuring glucose non-invasively will prevent gestational diabetes mellitus and preeclampsia during pregnancy

Secondary Outcome Measures

  1. Examine role of sleep as a potential mechanism in changing blood glucose in pregnancy [24-39 weeks]

    measuring glucose non-invasively may aid in sleep, thereby improving blood glucose

  2. Examine role of sleep as a potential mechanism in changing blood pressure in pregnancy [24-39 weeks]

    measuring glucose non-invasively may aid in sleep, thereby improving blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Virend Somers, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Virend Somers, MD, PhD, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04979312
Other Study ID Numbers:
  • 21-000284
First Posted:
Jul 28, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes, Gestational
Eclampsia
Pre-Eclampsia

Study Results

No Results Posted as of Jun 1, 2022