Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ascorbic acid solution (American Regent Laboratories Inc.), Saline.
- Who it may be relevant to
- Registry conditions: Hypertension, Cardiovascular Diseases. Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance
Overview
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.
Interventions
- Drug Ascorbic acid solution (American Regent Laboratories Inc.)
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. - Drug Saline
Placebo (saline) will be administered
Primary outcome measures
- Efficacy of infusion of ascorbic acid [Time frame: 30 minutes]
- Efficacy of infusion of ascorbic acid [Time frame: 60 minutes]
- Efficacy of infusion of ascorbic acid [Time frame: 90 minutes]
- Efficacy of infusion of ascorbic acid [Time frame: 120 minutes]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Diabetes mellitus: fasting glucose < 1267 mg/dL and/or HbA1c < 6.5%
- Currently taking a statin or antihypertension medication
- Hyperlipidemia: Fasting triglycerides < 250 mg/dL
- Hypertension: <130/80 mmHg
- History of heart disease (e.g., myocardial infarction, stent)
- History of vascular disease (e.g., bypass, stroke)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT04715022 · STUDY00146744