Gestational Complications, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Obesity and Obesity-related Medical Conditions, Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Pregnancy, Pregnancy Complications
Conditions
Keywords
metabolic dysfunction, gestational diabetes, pregnancy, maternal obesity, maternal insulin resistance, aspirin metabolism, GDM, substrate oxidation, gestational glucose intolerance
Brief summary
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.
Interventions
None listed
Sponsors
University of Tennessee Graduate School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist based on ACOG and USPSTF guidelines (1 high risk factor, 2+ moderate risk factors) * Willingness to adhere to aspirin therapy * Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc. * Gestational age at enrollment \<16 weeks * Ability to speak, read, and communicate via English
Exclusion criteria
* Type 2 Diabetes Mellitus * Type 1 Diabetes Mellitus * Current gestational diabetes mellitus * Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.) * Thrombophilia * Current use of NSAID for other indication (indomethacin, ibuprofen, etc.) * Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.) * Current or recent use of steroids * Current use of prophylactic or therapeutic anticoagulation * Medical contraindication to aspirin therapy * Molar pregnancy * Renal disease * Inability or unwillingness to give informed consent * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hexadecadienoate (z score) | 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age | Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score) |
| Salicylate (z score) | 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age | Salicylate (benzoate metabolite obtained from metabolomics assay)(z score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary thromboxane B2 level (pg/mg creat) | 60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age | Urinary thromboxane B2 level (pg/mg creat) |
| Fasting Salicylate level (ug/mL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting Salicylate level (ug/mL) in venous blood |
| 1 Hour Salicylate level (ug/mL) | 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age | 1 Hour Salicylate level (ug/mL) in venous blood |
| 2 Hour Salicylate level (ug/mL) | 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age | 2 Hour Salicylate level (ug/mL) in venous blood |
| Fasting PFA-100 epinephrine closure time | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting PFA-100 epinephrine closure time in venous blood |
| 1 Hour PFA-100 epinephrine closure time | 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age | 1 Hour PFA-100 epinephrine closure time in venous blood |
| 2 Hour PFA-100 epinephrine closure time | 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age | 2 Hour PFA-100 epinephrine closure time in venous blood |
| Homeostatic Model Assessment for Insulin Resistance | Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age | Approximates insulin resistance. |
| Fasting Resting Metabolic Rate | Measured at the start of a single study visit between 14-20 weeks gestational age | Resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry |
| Fasting cholesterol (mg/dL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting cholesterol level (mg/dL) in venous blood |
| Fasting Carbohydrate Oxidation Rate | Measured at the start of a single study visit between 14-20 weeks gestational age | Fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry |
| Fasting Lipid Oxidation Rate | Measured at the start of a single study visit between 14-20 weeks gestational age | Fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry |
| Fasting Insulin (mIU/mL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting insulin level (mIU/mL) in venous blood |
| Fasting glucose (mg/dL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting glucose level (mg/dL) in venous blood |
| Fasting lactate (mmol/L) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting lactate level (mmol/L) in venous blood |
| Fasting triglycerides (mg/dL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting triglycerides level (mg/dL) in venous blood |
| Fasting high density lipoprotein (mg/dL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting high density lipoprotein level (HDL) (mg/dL) in venous blood |
| Fasting very low density lipoprotein (mg/dL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood |
| Fasting low density lipoprotein (mg/dL) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting low density lipoprotein level (LDL) (mg/dL) in venous blood |
| Fasting Respiratory Quotient | Measured at the start of a single study visit between 14-20 weeks gestational age | Resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry |
| Fasting free fatty acids (mEq/L) | Fasting, at the beginning of a single study visit between 14-20 weeks gestational age | Fasting free fatty acids (FFA) (mEq/L) in venous blood |
Countries
United States
Contacts
Primary ContactJill M Maples, PhD
Outcome results
None listed