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Centro Medico Surocdental dell'Università del TexasLeg Heating in Pregnant Women With Obesity 118 Domiciliare Gravidanza
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La sperimentazione clinica NCT06932250 è uno studio interventistico per High-risk Pregnancy, attualmente in arruolamento. Avviato il 1 maggio 2025, prevede di arruolare 118 partecipanti. Sotto la guida di il Centro Medico Surocdental dell'Università del Texas, dovrebbe concludersi entro il 30 aprile 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 2 marzo 2026.
Sommario breve
Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are largely unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed to 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Additionally, augmented sympathetic vasoconstriction may also contribute...Mostra di più
Descrizione dettagliata
Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed in part to: 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Conversely, augmented sympathetic vasoconstriction may also contribute ...Mostra di più
Titolo ufficiale
Vascular and Neural Mechanisms of Chronic Leg Heating in Pregnant Women With Obesity
Patologie
High-risk PregnancyPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- STU20250500
Numero NCT
Data di inizio (effettiva)
2025-05-01
Ultimo aggiornamento pubblicato
2026-03-02
Data di completamento (stimata)
2030-04-30
Arruolamento (previsto)
118
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Pregnancy
Obesity
Heat therapy
Vascular function
Sympathetic neural control
Blood pressure
Obesity
Heat therapy
Vascular function
Sympathetic neural control
Blood pressure
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleSauna blanket set at 65°C The temperature of the sauna blanket will be set at 65°C and participants will perform home-based leg heating 4 times per week, 45 minutes per session. | Leg heating Participants will perform home-based leg heating using a portable sauna blanket set at different temperature. |
Comparatore placeboSauna blanket set at 35°C The temperature of the sauna blanket will be set at 35°C and participants will perform home-based leg heating 4 times per week, 45 minutes per session. | Leg heating Participants will perform home-based leg heating using a portable sauna blanket set at different temperature. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in vascular endothelial function | Change in vascular endothelial function assessed by brachial artery flow-mediated vasodilation using the Doppler ultrasound technique | Baseline, 16 weeks after leg heating |
Change in sympathetic neural control | Change in sympathetic neural control assessed by muscle sympathetic nerve (re)activity using the microneurographic technique | Baseline, 16 weeks after leg heating |
Change in sympathetic vascular transduction | Change in sympathetic vascular transduction assessed using the microneurographic and Doppler ultrasound techniques | Baseline, 16 weeks after leg heating |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in blood concentration of nitrate | Blood concentration of nitrate will be used to estimate nitric oxide bioavailability | Baseline, 16 weeks after leg heating |
Change in blood concentration of nitrite | Blood concentration of nitrite will be used to estimate nitric oxide bioavailability | Baseline, 16 weeks after leg heating |
Change in L-arginine level | Baseline, 16 weeks after leg heating | |
Change in asymmetric dimethylarginine level | Baseline, 16 weeks after leg heating | |
Change in 3-nitrotyrosine level | Baseline, 16 weeks after leg heating | |
Change in concentration of endothelin-1 | Baseline, 16 weeks after leg heating | |
Change in 24-hour ambulatory blood pressure | Baseline, 16 weeks after leg heating | |
Change in placental growth factor level | Baseline, 16 weeks after leg heating | |
Change in solube fms-like tyrosine kinase-1 level | Baseline, 16 weeks after leg heating | |
Change in soluble endoglin level | Baseline, 16 weeks after leg heating |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Femmina
Accetta volontari sani
Sì
- Women with overweight or obesity (self-reported pre-pregnancy body mass index ≥25 kg/m2) between 10-14 weeks of gestation and aged 18-45 years old will be enrolled.
- Both normotensive and hypertensive (office sitting systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg) pregnant women will be enrolled if they are not on any antihypertensive drug treatment.
- We will enroll both nulliparous and multiparous women.
- There is no restriction regarding race/ethnicity and socioeconomic status.
- Women with a history of HDP will be allowed to participate.
- Women taking low-dose aspirin will be allowed to participate and aspirin use will be documented.
- Current multiple pregnancies (e.g., twins, triplets, etc.).
- Known major fetal chromosomal or anatomical abnormalities diagnosed during the study.
- Recurrent miscarriage (three or more, to avoid antiphospholipid antibody syndrome).
- Office sitting BP <100/55 mmHg or >150/100 mmHg (for safety reasons).
- Evidence of cardiovascular, pulmonary, or neurological diseases.
- Diabetes mellitus (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction).
- Kidney disease (serum creatinine >0.9 mg/dL).
- Clinical known deep vein thrombosis, clinical symptoms and history of deep vein thrombosis, or dermatological lesions.
- History of drug or alcohol abuse within the last 2 years.
- Current tobacco use.
- Pregnant women who do not have air conditioning at home during summer (for safety reasons).
Centro Medico Surocdental dell'Università del TexasParte responsabile dello studio
Qi Fu, Investigatore principale, Professor, University of Texas Southwestern Medical Center
Contatti principali dello studio
Contatto: Qi Fu, MD, PhD, 214-345-8125, [email protected]
Contatto: Monique Roberts-Reeves, RN, 214-345-4656, [email protected]
1 Centri dello studio in 1 paesi
Texas
UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine, Dallas, Texas, 75231, United States
Monique Roberts-Reeves, RN, Contatto, 214-345-4656, [email protected]
In arruolamento