RECRUITING

Leg Heating in Pregnant Women With Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2030-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06932250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with obesity (self-reported pre-pregnancy body mass index ≥30 kg/m2) between 10-14 weeks of gestation and aged 18-45 years old will be enrolled.
  2. * Both normotensive and hypertensive (office sitting systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg)42 pregnant women will be enrolled if they are not on any antihypertensive drug treatment.
  3. * We will enroll both nulliparous and multiparous women.
  4. * There is no restriction regarding race/ethnicity and socioeconomic status.
  5. * Women with a history of HDP will be allowed to participate.
  6. * Women taking low-dose aspirin will be allowed to participate and aspirin use will be documented.
  1. * Current multiple pregnancies (e.g., twins, triplets, etc.).
  2. * Known major fetal chromosomal or anatomical abnormalities diagnosed during the study.
  3. * Recurrent miscarriage (three or more, to avoid antiphospholipid antibody syndrome).
  4. * Office sitting BP \<100/55 mmHg or \>150/100 mmHg (for safety reasons).
  5. * Severe sleep apnea (an apnea-hypopnea index ≥30 events/h43 based on the results from in-home sleep testing) or previously diagnosed and treated sleep apnea.
  6. * Evidence of cardiovascular, pulmonary, or neurological diseases.
  7. * Diabetes mellitus or a history of gestational diabetes (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction).
  8. * Kidney disease (serum creatinine \>0.9 mg/dL).44, 45
  9. * Psychiatric diseases or medically treated psychological disorders.
  10. * History of drug or alcohol abuse within the last 2 years.
  11. * Current tobacco use.
  12. * Pregnant women who do not have air conditioning at home during summer (for safety reasons).

Contacts and Locations

Study Contact

Qi Fu, MD, PhD
CONTACT
214-345-8125
QiFu@TexasHealth.org
Monique Roberts-Reeves, RN
CONTACT
214-345-4656
MoniqueRoberts-Reeves@TexasHealth.org

Principal Investigator

Qi Fu, MD, PhD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

Study Locations (Sites)

UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Qi Fu, MD, PhD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2030-05-31

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2030-05-31

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Obesity
  • Heat therapy
  • Vascular function
  • Sympathetic neural control
  • Blood pressure

Additional Relevant MeSH Terms

  • High-risk Pregnancy