What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease include statins, niacin, and vitamin therapies such as ascorbic acid (Vitamin C). Statins, which are used to lower cholesterol, can cause side effects like muscle pain, liver damage, and increased blood sugar levels. Niacin, another cholesterol-lowering agent, may lead to flushing, itching, and gastrointestinal issues. Ascorbic acid (Vitamin C) is generally well-tolerated but can cause gastrointestinal disturbances such as diarrhea and abdominal cramps at high doses. Additionally, high doses of vitamin C may interfere with certain medications and exacerbate conditions like kidney stones.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cardiovascular disease that focus on improving vascular health and reducing blood pressure. These include statins like atorvastatin, which lower cholesterol levels and improve endothelial function, and antihypertensive medications such as ACE inhibitors and beta-blockers, which help manage blood pressure. While ascorbic acid (Vitamin C) is being studied for its potential benefits in improving blood vessel function and reducing blood pressure, it is not yet FDA-approved specifically for cardiovascular disease treatment.

What other types of research exist?

Promising novel alternatives to ascorbic acid for cardiovascular disease patients include: 1) Antioxidant therapies such as Coenzyme Q10, which has shown potential in improving endothelial function and reducing oxidative stress. 2) Polyphenols, particularly those found in dark chocolate and green tea, which have been associated with improved vascular health and reduced blood pressure. 3) Omega-3 fatty acids, which have anti-inflammatory properties and can improve endothelial function. 4) Novel antihypertensive drugs targeting specific pathways involved in blood pressure regulation, such as endothelin receptor antagonists. These alternatives are supported by emerging research and may offer additional benefits for cardiovascular health.

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Vitamin

Vitamin C for Insulin Resistance

Phase 1 & 2

Recruiting

Led By Seth Holwerda, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Middle-aged: 35-65 years

Be older than 18 years old

Must not have

Currently taking a statin or antihypertension medication

History of vascular disease (e.g., bypass, stroke)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Summary

This trial is testing if Vitamin C can improve blood vessel health and lower blood pressure in obese adults who have difficulty processing sugar. These individuals often have high blood pressure and a higher risk of heart disease. Vitamin C might help by making blood vessels healthier and calming the nerves that control them. Vitamin C has been studied for its potential benefits in reducing blood pressure and improving heart health, though results have been inconsistent.

Who is the study for?

This trial is for obese adults aged 35-65 with insulin resistance. Participants must not be taking statins, antihypertension meds, or have a history of heart or vascular disease. They should stop vitamin C/E and omega-3 supplements two weeks before the study.

What is being tested?

The study tests how well Vitamin C (ascorbic acid solution) can improve blood vessel function in comparison to saline in people with insulin resistance. It aims to see if Vitamin C can lower high blood pressure by improving vascular health.

What are the potential side effects?

Potential side effects from ascorbic acid may include digestive discomfort, such as stomach cramps or diarrhea, and possibly an increased risk of kidney stones if taken in large doses over long periods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for high cholesterol or high blood pressure.

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I have a history of vascular disease.

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I have a history of heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of infusion of ascorbic acid

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ascorbic acid infusionActive Control1 Intervention

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.

Group II: Placebo infusionPlacebo Group1 Intervention

Saline will be administered over 2 hours

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiovascular disease (CVD) include statins, GLP-1-based therapies, and vitamin C. Statins work by inhibiting the enzyme HMG-CoA reductase, which reduces cholesterol synthesis in the liver, thereby lowering LDL cholesterol levels and improving endothelial function. GLP-1-based therapies help reduce atherosclerosis by lowering total cholesterol, LDL cholesterol, and triglycerides, and improving endothelial function. Vitamin C, an antioxidant, enhances blood vessel function and reduces blood pressure by improving endothelial function and reducing oxidative stress. These mechanisms are crucial for CVD patients as they help prevent the progression of atherosclerosis, reduce the risk of heart attacks and strokes, and improve overall cardiovascular health.

Effects of colestipol-niacin therapy on human femoral atherosclerosis.Mechanisms of anthracycline-mediated cardiotoxicity and preventative strategies in women with breast cancer.Anti-atherosclerotic effects of the glucagon-like peptide-1 (GLP-1) based therapies in patients with type 2 Diabetes Mellitus: A meta-analysis.