PreeclampsiaCAPNCT07565727
Cardiometabolic Disease and Substrate Metabolism
An observational study of Preeclampsia and Gestational Diabetes Mellitus (GDM), run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Gestational Diabetes Mellitus (GDM), Preeclampsia (PE)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to Aug 2027
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant individuals at risk for preeclampsia
Who may be able to join
- Age 18-45
- Any pre-pregnancy BMI
- At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines
- Willingness to adhere to aspirin therapy
- Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
- Gestational age at enrollment <18 weeks
- Ability to speak, read, and communicate via English
Who cannot join
- 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.)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
Jill M Maples, PhD, 865-305-9367, jmaples1@utmck.edu
Hana O El-Messidi, BS, 865-305-5592, hel1@utmck.edu
About this study
Official title: Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.
Read the detailed description
Cardiometabolic disease such as pre-eclampsia (PreE) and gestational diabetes (GDM) affect close to 15% of pregnancies and are a major cause of maternal and neonatal morbidity and mortality. Much of the clinical data surrounding these disorders focuses on management during pregnancy and counseling regarding risks of continued cardiometabolic dysfunction after pregnancy. Data are much more limited regarding assessing and managing cardiometabolic dysfunction leading into or early in pregnancy. Furthermore, there are even less data describing metabolic dysfunction outside of GDM and PreE as relate to future cardiometabolic risk.
The standard of care of assessing metabolic dysfunction during pregnancy, specifically gestational diabetes, is a two-step glucose challenge approach. Outside of pregnant populations, metabolic dysfunction is assessed from a more holistic approach including assessment of insulin, lactate, triglycerides, HDL, LDL, VDRL, cholesterol and free fatty acids.
Data are currently lacking on substrate metabolism other than glucose in pregnancy. There are some data that describe maternal lipid metabolism in pregnancy, but most of these data focus on lipid metabolism as it relates to fetal growth and fat mass, but none describe substrate metabolism as it relates to development of maternal disease such as insulin resistance.
Additionally, the placenta is an extremely metabolically active organ that responds to changes in maternal stress. There is evidence in animal studies that the placenta can alter transportation of carbohydrates, lipids and amnio acids in response to changes in heat, undernutrition, hypoglycemia and glucocorticoid administration.
Traditional hypotheses regarding development of cardiometabolic disease in pregnancy surrounded topics such as abnormal placentation, dysfunctional spiral arteries and hormones such as human placental lactogen. Outside of pregnancy, studies have shown that endothelial dysfunction has been linked to cardiometabolic disease due to its role in regulating vascular tone and glycolysis. Furthermore, there is evidence to support that gestational diabetes is a risk factor for development of endothelial dysfunction; however, in vivo endothelial dysfunction in GDM is not well explored. While there are data that describe endothelial dysfunction in pregnancy as it relates to pre-eclampsia, most studies describe indirect measures of endothelial dysfunction using proteins such as VEGF, PLGF, and SFLT1.
The metabolic profiles in pregnant people at risk for cardiometabolic disease has not been explored heavily. By assessing both maternal substrate metabolism as well as placental function and pathology, we hope to better understand disease from the lens of not just the maternal but also the fetal and placental unit. Therefore, this study seeks to evaluate the relationship between substrate metabolism of pregnant individuals as it relates to their development of cardiometabolic disease in pregnancy with hopes for more translational research to design better targeted therapies.
- Conditions
- Preeclampsia, Gestational Diabetes Mellitus (GDM), Preeclampsia (PE), Preeclampsia (PE) Risk, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
- Keywords
- Cardiometabolic disease, Substrate metabolism, Preeclampsia, Gestational Diabetes, Insulin resistance, HOMA-IR, Lipid oxidation, Placental dysfunction, Chorangiosis
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational, Insulin Resistance, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant individuals at risk for cardiometabolic disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Pregnancy Fasting Insulin (mIU/mL)
Early pregnancy fasting insulin level (mIU/mL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Homeostatic Model Assessment for Insulin Resistance
Approximates early pregnancy insulin resistance.
Measured: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Lipid Oxidation Rate (g/min)
Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 12-18 weeks gestational age
Late Pregnancy Fasting Insulin (mIU/mL)
Late pregnancy fasting insulin level (mIU/mL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Homeostatic Model Assessment for Insulin Resistance
Approximates late pregnancy insulin resistance.
Measured: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Lipid Oxidation Rate (g/min)
Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 26-30 weeks gestational age
Secondary outcomes (22)
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Early pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Resting Respiratory Quotient
Early pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
Early pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Glucose (mg/dL)
Early pregnancy fasting glucose level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Lactate (mmol/L)
Early pregnancy fasting lactate level (mmol/L) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Triglycerides (mg/dL)
Early pregnancy fasting triglycerides level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting High Density Lipoprotein (mg/dL)
Early pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
Early pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Low Density Lipoprotein (mg/dL)
Early pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Cholesterol (mg/dL)
Early pregnancy fasting cholesterol level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Free Fatty Acids (mEq/L)
Early pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
Measured: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Late Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Late pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Resting Respiratory Quotient
Late pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
Late pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
Measured: Measured at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Glucose (mg/dL)
Late pregnancy fasting glucose level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Lactate (mmol/L)
Late pregnancy fasting lactate level (mmol/L) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Triglycerides (mg/dL)
Late pregnancy fasting triglycerides level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting High Density Lipoprotein (mg/dL)
Late pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
Late pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Low Density Lipoprotein (mg/dL)
Late pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Cholesterol (mg/dL)
Late pregnancy fasting cholesterol level (mg/dL) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Free Fatty Acids (mEq/L)
Late pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
Measured: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Dec 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565727
- Sponsor's protocol ID
- 5483
- Acronym
- CAP
- Status last verified
- Jan 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reasonable requests will be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
- ClinicalTrials.gov ID
- NCT07565727
- Acronym / sponsor ID
- CAP / 5483
- Conditions
- Preeclampsia, Gestational Diabetes Mellitus (GDM), Preeclampsia (PE), Preeclampsia (PE) Risk, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
- Keywords
- Cardiometabolic disease, Substrate metabolism, Preeclampsia, Gestational Diabetes, Insulin resistance, HOMA-IR, Lipid oxidation, Placental dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.
Detailed description
Cardiometabolic disease such as pre-eclampsia (PreE) and gestational diabetes (GDM) affect close to 15% of pregnancies and are a major cause of maternal and neonatal morbidity and mortality. Much of the clinical data surrounding these disorders focuses on management during pregnancy and counseling regarding risks of continued cardiometabolic dysfunction after pregnancy. Data are much more limited regarding assessing and managing cardiometabolic dysfunction leading into or early in pregnancy. Furthermore, there are even less data describing metabolic dysfunction outside of GDM and PreE as relate to future cardiometabolic risk.
The standard of care of assessing metabolic dysfunction during pregnancy, specifically gestational diabetes, is a two-step glucose challenge approach. Outside of pregnant populations, metabolic dysfunction is assessed from a more holistic approach including assessment of insulin, lactate, triglycerides, HDL, LDL, VDRL, cholesterol and free fatty acids.
Data are currently lacking on substrate metabolism other than glucose in pregnancy. There are some data that describe maternal lipid metabolism in pregnancy, but most of these data focus on lipid metabolism as it relates to fetal growth and fat mass, but none describe substrate metabolism as it relates to development of maternal disease such as insulin resistance.
Additionally, the placenta is an extremely metabolically active organ that responds to changes in maternal stress. There is evidence in animal studies that the placenta can alter transportation of carbohydrates, lipids and amnio acids in response to changes in heat, undernutrition, hypoglycemia and glucocorticoid administration.
Traditional hypotheses regarding development of cardiometabolic disease in pregnancy surrounded topics such as abnormal placentation, dysfunctional spiral arteries and hormones such as human placental lactogen. Outside of pregnancy, studies have shown that endothelial dysfunction has been linked to cardiometabolic disease due to its role in regulating vascular tone and glycolysis. Furthermore, there is evidence to support that gestational diabetes is a risk factor for development of endothelial dysfunction; however, in vivo endothelial dysfunction in GDM is not well explored. While there are data that describe endothelial dysfunction in pregnancy as it relates to pre-eclampsia, most studies describe indirect measures of endothelial dysfunction using proteins such as VEGF, PLGF, and SFLT1.
The metabolic profiles in pregnant people at risk for cardiometabolic disease has not been explored heavily. By assessing both maternal substrate metabolism as well as placental function and pathology, we hope to better understand disease from the lens of not just the maternal but also the fetal and placental unit. Therefore, this study seeks to evaluate the relationship between substrate metabolism of pregnant individuals as it relates to their development of cardiometabolic disease in pregnancy with hopes for more translational research to design better targeted therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant individuals at risk for cardiometabolic disease | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant individuals at risk for preeclampsia
Key inclusion criteria (7 listed)
- Age 18-45
- Any pre-pregnancy BMI
- At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines
- Willingness to adhere to aspirin therapy
- Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Pregnancy Fasting Insulin (mIU/mL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early pregnancy fasting insulin level (mIU/mL) in venous blood
Early Pregnancy Homeostatic Model Assessment for Insulin Resistance
Time frame: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age
Approximates early pregnancy insulin resistance.
Early Pregnancy Fasting Lipid Oxidation Rate (g/min)
Time frame: Measured at the start of a single study visit between 12-18 weeks gestational age
Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
Late Pregnancy Fasting Insulin (mIU/mL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late pregnancy fasting insulin level (mIU/mL) in venous blood
Late Pregnancy Homeostatic Model Assessment for Insulin Resistance
Time frame: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age
Approximates late pregnancy insulin resistance.
Late Pregnancy Fasting Lipid Oxidation Rate (g/min)
Time frame: Measured at the start of a single study visit between 26-30 weeks gestational age
Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
22 secondary outcomes
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Time frame: Measured at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Resting Respiratory Quotient
Time frame: Measured at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
Time frame: Measured at the start of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Glucose (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Lactate (mmol/L)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Triglycerides (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting High Density Lipoprotein (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Low Density Lipoprotein (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Cholesterol (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Early Pregnancy Fasting Free Fatty Acids (mEq/L)
Time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
Late Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Time frame: Measured at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Resting Respiratory Quotient
Time frame: Measured at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
Time frame: Measured at the start of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Glucose (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Lactate (mmol/L)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Triglycerides (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting High Density Lipoprotein (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Low Density Lipoprotein (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Cholesterol (mg/dL)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Late Pregnancy Fasting Free Fatty Acids (mEq/L)
Time frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Reasonable requests will be considered on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Gestational Diabetes Mellitus (GDM), run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill M Maples, PhD (865-305-9367, jmaples1@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Pregnancy Fasting Insulin (mIU/mL) (time frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.