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Vitamin C for Type 2 Diabetes

Phase 1
Recruiting
Led By Ifechukwude C Ebenuwa, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Blood pressure with or without medication <160/90 mmHg with no known significant target organ damage (end organ damage includes the following: proliferative retinopathy, serum creatinine >1.5 or EGFR < 55 mL/min, symptomatic ischemic heart disease, severe congestive heart failure, advanced peripheral vascular disease.
Diabetes type 2 HgA1C less than or equal to 12 percent on insulin and/or oral hypoglycemic agents.
Must not have
Stage 1 and 2: Any subjective or objective evidence of microangiopathy such as history of claudication, symptomatic peripheral vascular disease, symptomatic coronary artery disease, stroke, retinopathy, nephropathy
Stage 1 and 2: Diabetic subjects with retinopathy to avoid accelerated retinopathy with hyperglycemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights

Summary

This trial will investigate whether vitamin C can help prevent microvascular disease in type II diabetes.

Who is the study for?
Adults aged 18-65 with Type 2 Diabetes, having an HgA1C of <=12% and generally in good health can join this trial. They must be on insulin or oral hypoglycemic agents, have controlled blood pressure, and agree to use contraception if female. Those with mild diseases like hypothyroidism may participate. People with severe illnesses, diabetic complications, or a history of non-compliance are excluded.
What is being tested?
The study is testing whether Vitamin C supplements can improve the flexibility of red blood cells (RBCs) in people with diabetes by reducing microvascular damage. Participants will undergo two hospital stays for monitoring without and then with Vitamin C supplementation to see if there's any change in RBC rigidity related to their glucose levels.
What are the potential side effects?
Vitamin C and E supplements used in this trial are considered safe at the prescribed doses; however, potential side effects could include digestive discomfort or allergic reactions. The risk associated with these vitamins is minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood pressure is under control, and I don't have serious heart, kidney, or blood vessel problems.
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My type 2 diabetes is managed and my HgA1C is 12% or lower.
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I am in good health with no major illnesses.
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My blood pressure is under 160/90 mmHg, with or without medication, and I have no significant organ damage.
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My vitamin C levels are above 30 uM before hospital studies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have signs of blood vessel damage, like pain while walking, heart issues, stroke, or eye/kidney problems.
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I have diabetes with eye problems and need to control my blood sugar to prevent worsening.
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I am unable or unwilling to give consent for the trial.
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I have had diabetic ketoacidosis or a hyperosmolar coma.
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I do not have severe heart, liver, or other systemic diseases.
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I do not have type 1 diabetes.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Whether RBCs have low vitamin C concentrations in patients with poorly controlled diabetes, as measured by Hba1C.
Whether acute changes in glycemia and/or red blood cell ascorbate (vitamin C) modify RBC deformability.
Whether acute glycemic control affects urinary leakage of ascorbate (vitamin C).
+1 more
Secondary study objectives
Whether RBC deformability is affected by vitamin C supplementation.
Whether RBC vitamin C concentrations can be increased by vitamin Csupplementation over several weeks in diabetic subjects.

Side effects data

From 2020 Phase 2 trial • 34 Patients • NCT01905150
22%
Nausea
11%
Insomnia
11%
Anorexia
11%
Anemia
11%
Fatigue
6%
Depression
6%
Diarrhea
6%
Pain
6%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stage 2Experimental Treatment1 Intervention
Subjects may be considered for arm stage 2 inpatient study no less than 8 weeks duration from arm stage 1 study. Once the RBC vitamin C concentrations are optimal (\>30 uM), subjects may be re-admitted to Clinical Center metabolic unit and undergo the same protocol as described above in arm stage 1. Oral vitamin C and E supplementation may be discontinued on admission. The inpatient diet, glucose monitoring and sampling scheme will be the same as described for the first inpatient study.
Group II: Stage 1Experimental Treatment1 Intervention
Upon admission, diabetic subjects maywill discontinue their oral hypoglycemic medications and/or insulin regimen per investigators discretion. Oral hypoglycemic agents and/or insulin doses will be adjusted and may be supplemented with a correction scale and/or and transitioned to a basal-bolus insulin regimen. In order to achieve optimal glycemic monitoring and for safety reasons, subjects may be fitted with a Dexcom continuous glucose monitor (CGM) upon inpatient admission. CGM will be used to supplement, rather than replace, fingerstick glucose measurements. CGM monitoring will include a sensor fitted subcutaneously, a wireless transmitter that allows for remote glucose monitoring by the research team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin C
2017
Completed Phase 4
~18470

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,410 Previous Clinical Trials
4,324,791 Total Patients Enrolled
109 Trials studying Diabetes
138,677 Patients Enrolled for Diabetes
Ifechukwude C Ebenuwa, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
5,000 Total Patients Enrolled
1 Trials studying Diabetes
5,000 Patients Enrolled for Diabetes

Media Library

Vitamin C Clinical Trial Eligibility Overview. Trial Name: NCT02107976 — Phase 1
Diabetes Clinical Trial 2023: Vitamin C Highlights & Side Effects. Trial Name: NCT02107976 — Phase 1
Vitamin C 2023 Treatment Timeline for Medical Study. Trial Name: NCT02107976 — Phase 1
~5 spots leftby Dec 2024
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