Blood Pressure, Gestational Diabetes, Pre-Eclampsia
Conditions
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.
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.
Interventions
DEVICELabClasp
Subjects will complete up to 10 measurements per day with potentially more before and during their OGTT using the LabClasp
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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 * 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 or preeclampsia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30 | Blood Glucose will be measured in Mmol/L |
| Systolic Blood Pressure | Baseline | Systolic Blood Pressure will be measured in mmHg |
| Diastolic Blood Pressure | Baseline | Diastolic Blood Pressure will be measured in mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh sleep study quality index | Baseline | The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVirend Somers, MD, PhD
Mayo Clinic
Outcome results
None listed