- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07565727
Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jill M Maples, PhD
- Numer telefonu: 865-305-9367
- E-mail: jmaples1@utmck.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Hana O El-Messidi, BS
- Numer telefonu: 865-305-5592
- E-mail: hel1@utmck.edu
Lokalizacje studiów
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Tennessee
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Knoxville, Tennessee, Stany Zjednoczone, 37920
- Rekrutacyjny
- University of Tennessee Graduate School of Medicine
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Kontakt:
- Jill M Maples, PhD
- Numer telefonu: 865-305-9367
- E-mail: jmaples1@utmck.edu
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Kontakt:
- Hana O El-Messidi, BS
- Numer telefonu: 865-305-5592
- E-mail: hel1@utmck.edu
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Główny śledczy:
- Jacklyn Locklear, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 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
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Pregnant individuals at risk for cardiometabolic disease
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Early Pregnancy Fasting Insulin (mIU/mL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting insulin level (mIU/mL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Homeostatic Model Assessment for Insulin Resistance
Ramy czasowe: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age
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Approximates early pregnancy insulin resistance.
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Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Lipid Oxidation Rate (g/min)
Ramy czasowe: Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Late Pregnancy Fasting Insulin (mIU/mL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting insulin level (mIU/mL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late Pregnancy Homeostatic Model Assessment for Insulin Resistance
Ramy czasowe: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age
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Approximates late pregnancy insulin resistance.
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Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age
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Late Pregnancy Fasting Lipid Oxidation Rate (g/min)
Ramy czasowe: Measured at the start of a single study visit between 26-30 weeks gestational age
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Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 26-30 weeks gestational age
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Ramy czasowe: Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Resting Respiratory Quotient
Ramy czasowe: Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
Ramy czasowe: Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Glucose (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting glucose level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Lactate (mmol/L)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting lactate level (mmol/L) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Triglycerides (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting triglycerides level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting High Density Lipoprotein (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Low Density Lipoprotein (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Cholesterol (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting cholesterol level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Free Fatty Acids (mEq/L)
Ramy czasowe: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Late Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Ramy czasowe: Measured at the start of a single study visit between 26-30 weeks gestational age
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Late pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Resting Respiratory Quotient
Ramy czasowe: Measured at the start of a single study visit between 26-30 weeks gestational age
|
Late pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
Ramy czasowe: Measured at the start of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Glucose (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting glucose level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late Pregnancy Fasting Lactate (mmol/L)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting lactate level (mmol/L) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late Pregnancy Fasting Triglycerides (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting triglycerides level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late Pregnancy Fasting High Density Lipoprotein (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
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Late Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
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Late Pregnancy Fasting Low Density Lipoprotein (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
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Late Pregnancy Fasting Cholesterol (mg/dL)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting cholesterol level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
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Late Pregnancy Fasting Free Fatty Acids (mEq/L)
Ramy czasowe: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby układu hormonalnego
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Choroby metaboliczne
- Zaburzenia metabolizmu glukozy
- Cukrzyca
- Nadciśnienie tętnicze wywołane ciążą
- Hiperinsulinizm
- Choroby żywieniowe i metaboliczne
- Cukrzyca, Ciąża
- Stan przedrzucawkowy
- Powikłania ciąży
- Insulinooporność
Inne numery identyfikacyjne badania
- 5483
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Insulinooporność
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Instituto de Investigacion Sanitaria La FeRekrutacyjnyCukrzyca typu 2 (T2DM) | Ciągłe monitorowanie poziomu glukozy | CGM | Przejście na rozładowanie | Smart Insulin Pen CapHiszpania