Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance

Who is this study for? Adult patients age 35 to 65 with hypertension
What treatments are being studied? Ascorbic acid solution
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD). This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
View:

• Obese: BMI \>30 m/kg2

• Middle-aged: 35-65 years

• 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

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Seth Holwerda, PhD
sholwerda@kumc.edu
9729223230
Backup
Manuel Clark, MPA
mclark16@kumc.edi
913-945-5763
Time Frame
Start Date: 2021-06-17
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 23
Treatments
Placebo_comparator: Placebo infusion
Saline will be administered over 2 hours
Active_comparator: Ascorbic acid infusion
Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the University of Kansas (KU) Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a drip-infusion of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov