RECRUITING

Reversing Glucose and Lipid-mediated Vascular Dysfunction

Conditions

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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 our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure.

Official Title

Reversing Glucose and Lipid-mediated Vascular Dysfunction (REGAL)

Quick Facts

Study Start:2022-05-09

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04832009

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:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Lean: BMI \< 25 kg/m * Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood) * Middle-aged: 18-79 years * Blood pressure: \< 140 (systolic) and \< 90 mmHg (diastolic * Weight stable (+/- 5 lbs) for the previous 3 months * Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior. * Able and willing to provide written informed consent	* Diabetes mellitus Type I or Type II: fasting glucose \< 126 mg/dL and/or HbA1c \< 6.5% * Current smoker or History of smoking in the past 3 months. * Hyperlipidemia: Fasting triglycerides \< 250 mg/dL * Hypertension: \>130/80 mmHg * History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy) * History of vascular disease (e.g., bypass, stroke)

Inclusion Criteria

Exclusion Criteria

* Lean: BMI \< 25 kg/m
* Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood)
* Middle-aged: 18-79 years
* Blood pressure: \< 140 (systolic) and \< 90 mmHg (diastolic
* Weight stable (+/- 5 lbs) for the previous 3 months
* Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
* Able and willing to provide written informed consent

* Diabetes mellitus Type I or Type II: fasting glucose \< 126 mg/dL and/or HbA1c \< 6.5%
* Current smoker or History of smoking in the past 3 months.
* Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
* Hypertension: \>130/80 mmHg
* History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)
* History of vascular disease (e.g., bypass, stroke)

Contacts and Locations

Study Contact

Seth W Holwerda, PhD

CONTACT

9729223230

sholwerda@kumc.edu

Davina A Clonch

CONTACT

9132266009

shoggirl@gmail.com

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 Date2022-05-09

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2022-05-09

Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

Blood Pressure
Hypertension