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Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
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.
Conditions:
🦠 Hypertension 🦠 Cardiovascular Diseases
🗓️ Study Start (Actual) 17 June 2021
🗓️ Primary Completion (Estimated) 1 April 2025
✅ Study Completion (Estimated) 1 April 2025
👥 Enrollment (Estimated) 23
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Kansas City, Kansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Obese: BMI \>30 m/kg2
    • 2. Middle-aged: 35-65 years
    • 3. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
    • 4. Able and willing to provide written informed consent

    Exclusion Criteria:

    • 1. Diabetes mellitus: fasting glucose \< 1267 mg/dL and/or HbA1c \< 6.5%
    • 2. Currently taking a statin or antihypertension medication
    • 3. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
    • 4. Hypertension: \<130/80 mmHg
    • 5. History of heart disease (e.g., myocardial infarction, stent)
    • 6. History of vascular disease (e.g., bypass, stroke)
Ages Eligible for Study: 35 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 10 January 2021
  • First Submitted that Met QC Criteria 14 January 2021
  • First Posted 20 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 October 2023
  • Last Update Posted 24 October 2023
  • Last Verified October 2023
I'm interested ...!!