Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT04715022
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ascorbic acid solution (American Regent Laboratories Inc.) — DRUG
    Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the 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.
  • Saline — DRUG
    Placebo (saline) will be administered

Study Details

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.

Key Dates

Start date
Jun 17, 2021
Status verified
Jun 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
23 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Efficacy of infusion of ascorbic acid [ Time Frame: 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Davina Clonch
[email protected]
913-226-6009
Megan Gangwish
[email protected]
913-444-0949

Find similar trials in Kansas City, KS

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Kansas Medical Center· Kansas City, KS

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