RecruitingNot ApplicableNCT06932250

Leg Heating in Pregnant Women With Obesity

Vascular and Neural Mechanisms of Chronic Leg Heating in Pregnant Women With Obesity


Sponsor

University of Texas Southwestern Medical Center

Enrollment

118 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 to HDP. Chronic (repeated) whole-body heat exposure has been shown to increase NO bioavailability, decrease ET-1, and cause functional and structural adaptations in the vasculature. All these can improve vascular function, attenuate sympathetic (re)activity, lower blood pressure (BP), and reduce cardiovascular risk in non-pregnant individuals. Whether this is also true after regional (leg) heating in high-risk pregnant women is unknown. The investigators' central hypothesis is that chronic leg heating will be effective in improving vascular endothelial function and attenuating sympathetic vasoconstriction, leading to a reduction of the risk for HDP in pregnant women with obesity. The overarching goal of this proposal is to determine the vascular and neural effects of chronic leg heating in obese pregnancy. The study team plans to enroll pregnant women with obesity between 12-14 weeks of gestation and randomly assign them to either an intervention group or a control group (1:1 ratio). Participants in the intervention group will perform 16 weeks of home-based leg heating using a portable sauna blanket up to the hip (temperature of the blanket will be set at 65°C, 4 times/week, 45 min/session), whereas women in the control group will set the temperature of the blanket at 35°C at the same frequency and duration. Participants will be evaluated at baseline and then at 28-30 weeks of gestation. Aim 1 will determine the effects of chronic leg heating on maternal vascular function and surrogate markers of HDP. Aim 2 will determine the effects of chronic leg heating on sympathetic vasoconstriction and BP. Findings from this project will provide insight on the extent and potential mechanisms of how chronic leg heating works for improving vascular endothelial function and sympathetic vasoconstriction in pregnant women with obesity. Results obtained will set a foundation for future large multicenter clinical trials to determine the efficacy and generalizability of home-based leg heat therapy as a safe, ease-of-use, cost-effective, and non-drug approach for reducing the risk of HDP.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether applying heat to the legs four times per week using a portable sauna blanket during pregnancy can improve blood vessel function and reduce the risk of high blood pressure complications (hypertensive disorders of pregnancy) in women who are overweight or obese. Obesity raises the risk of serious pregnancy complications by impairing blood vessel health, and heat therapy has shown promise in improving vascular function in non-pregnant people. Pregnant women aged 18 to 45 with a pre-pregnancy BMI of 25 or higher, between 10 and 14 weeks of gestation, and not on blood pressure medication are eligible, excluding those with multiple pregnancies, diabetes, kidney disease, or cardiovascular disease. Participants will use a leg heating blanket at home for 16 weeks and attend two in-clinic visits for vascular assessments at the start and at 28–30 weeks of pregnancy. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLeg heating

Participants will perform home-based leg heating using a portable sauna blanket set at different temperature.


Locations(1)

UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

Dallas, Texas, United States

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NCT06932250


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