23 Participants Needed

Vitamin C for Insulin Resistance

SH
MC
Overseen ByManuel Clark, MPA
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Kansas Medical Center
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any vitamin C or E supplements or omega-3 fatty acids starting 2 weeks before joining. If you are currently taking statins or antihypertension medications, you cannot participate in the trial.

Is Vitamin C safe for humans?

Vitamin C is generally considered safe for humans, but taking very high doses might affect how your body handles sugar, as seen in a study where a large amount of Vitamin C delayed the body's insulin response to sugar intake.12345

How does the treatment Vitamin C differ from other treatments for insulin resistance?

Vitamin C is unique in treating insulin resistance because it acts as an antioxidant, reducing oxidative stress and inflammation, which are key factors in insulin resistance. Unlike some other treatments, it can improve insulin sensitivity by targeting these underlying issues, and it is administered orally as a simple vitamin supplement.12346

What data supports the effectiveness of the treatment Vitamin C for insulin resistance?

Research suggests that Vitamin C, an antioxidant, may help improve insulin resistance by reducing inflammation and improving glucose uptake in cells. Studies have shown that Vitamin C deficiency can worsen insulin resistance, while supplementation may help improve metabolic disorders.13478

Who Is on the Research Team?

SH

Seth Holwerda, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to stop taking vitamin C, E, or omega-3 supplements 2 weeks before.
Able and willing to provide written informed consent
You are very overweight, with a BMI over 30.
See 1 more

Exclusion Criteria

I am currently on medication for high cholesterol or high blood pressure.
I have a history of vascular disease.
I have a history of heart disease.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or ascorbic acid infusion to assess the impact on blood vessel function and blood pressure

2 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ascorbic acid
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Ascorbic acid infusionActive Control1 Intervention
Group II: Placebo infusionPlacebo Group1 Intervention

Ascorbic acid is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Vitamin C for:
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Approved in European Union as Vitamin C for:
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Approved in Canada as Vitamin C for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

Published Research Related to This Trial

In a study involving 16 obese male volunteers, a daily oral supplement of 1 g of ascorbic acid (AA) for four weeks did not lead to significant changes in lipid profiles or insulin sensitivity compared to a placebo group.
The results indicate that ascorbic acid supplementation may not be effective in improving metabolic health markers in obese individuals, as no significant differences were observed before and after the intervention.
[Effect of oral administration of ascorbic acid on insulin sensitivity and lipid profile in obese individuals].Martínez-Abundis, E., Pascoe-González, S., González-Ortiz, M., et al.[2013]
A systematic review of 14 randomized controlled trials involving 735 patients with type 2 diabetes found that neither vitamin C nor vitamin E supplementation significantly improved insulin resistance, as measured by the HOMA index.
The study concluded that taking vitamin C, vitamin E, or their combination does not enhance insulin resistance in individuals with type 2 diabetes, indicating that these supplements may not be effective for this purpose.
Effect of vitamins C and E on insulin resistance in diabetes: a meta-analysis study.Khodaeian, M., Tabatabaei-Malazy, O., Qorbani, M., et al.[2022]
Ascorbic acid (AA) supplementation showed a significant reduction in fasting blood sugar (FBS) levels in type 2 diabetes patients based on a meta-analysis of 5 randomized controlled trials, indicating potential short-term benefits.
However, there is insufficient evidence regarding the long-term safety and efficacy of AA for managing diabetes, and the effect on glycated hemoglobin (HbA1c) was not significant, suggesting caution in recommending long-term use.
Influence of ascorbic acid supplementation on type 2 diabetes mellitus in observational and randomized controlled trials; a systematic review with meta-analysis.Tabatabaei-Malazy, O., Nikfar, S., Larijani, B., et al.[2022]

Citations

[Effect of oral administration of ascorbic acid on insulin sensitivity and lipid profile in obese individuals]. [2013]
Effect of vitamins C and E on insulin resistance in diabetes: a meta-analysis study. [2022]
Influence of ascorbic acid supplementation on type 2 diabetes mellitus in observational and randomized controlled trials; a systematic review with meta-analysis. [2022]
Does diabetes mellitus increase the requirement for vitamin C? [2019]
Vitamin C deficiency aggravates tumor necrosis factor α-induced insulin resistance. [2018]
Ascorbic acid supplementation improves skeletal muscle oxidative stress and insulin sensitivity in people with type 2 diabetes: Findings of a randomized controlled study. [2022]
Megadose of vitamin C delays insulin response to a glucose challenge in normoglycemic adults. [2018]
Ascorbic acid reduces insulin resistance and pancreatic steatosis by regulating adipocyte hypertrophy in obese ovariectomized mice. [2023]
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