RECRUITING

Mitigating the Pro-inflammatory Phenotype of 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

The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.

Official Title

Mitigating the Pro-inflammatory Phenotype of Obesity

Quick Facts

Study Start:2021-07-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04934228

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 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female, age 18-79
  2. * Obese: BMI \> 30 m/kg2
  3. * Hypertensive: blood pressure \>130/80
  4. * Elevated insulin resistance (HOMA-IR \> 2.5)
  5. * Waist circ: \>102 cm (men) and \>88 cm (women)
  6. * Fasting glucose \< 126 mg/dL
  7. * Fasting triglycerides \< 250 mg/dL
  8. * HbA1c \< 6.5%
  9. * Willing to visit research lab (Fairway CTSU)
  10. * Willing to undergo a blood draw
  11. * Able to provide written informed consent
  1. * Current use of clonidine or beta-blockers
  2. * Current smoker or History of smoking in the past 3 months.
  3. * Hyperlipidemia: Fasting triglycerides \> 250 mg/dL
  4. * Currently taking hypertension medication
  5. * History of heart disease (e.g., myocardial infarction, stent, byass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)
  6. * History of neurological disorders
  7. * History of transplant
  8. * Actively participating in other studies, except for a registry study.

Contacts and Locations

Study Contact

Seth W Holwerda, Ph,D
CONTACT
9729223230
sholwerda@kumc.edu
Davina A Clonch
CONTACT
9132266009
dclonch@kumc.edu

Principal Investigator

Seth W. W Holwerda, PhD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66103
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Seth W. W Holwerda, PhD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

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 Date2021-07-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Blood Pressure
  • Diabetes
  • Obesity
  • Insulin Resistance
  • Diuretics Drug Reactions
  • Sympathetic Nerve Activity