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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 from stage 1 to stage 2

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from stage 1 to stage 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from stage 1 to stage 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and from stage 1 to stage 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in RBC deformability elongation indices (EI) from stage 1 to stage 2

Change in RBC deformability half maximal shear stress (SS0.5) from stage 1 to stage 2

Change in RBC deformability maximum elongation indices (EImax) from stage 1 to stage2

Secondary study objectives

Change in RBC deformability elongation indices

Change in RBC deformability half-maximal shear stress (SS0.5)

Change in RBC deformability maximum elongation indices (EImax)

+11 more

Side effects data

From 2020 Phase 2 trial • 34 Patients • NCT01905150

21%

Nausea

14%

Fatigue

14%

Depression

14%

Diarrhea

14%

Pain

14%

Anxiety

Anemia

Ascites

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC

G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage 2Experimental Treatment2 Interventions

Inpatient admission to NIH CC after at least 8 weeks of vitamin C and vitamin E supplementation. Testing periods include: euglycemic period with serial blood and urine sampling followed by hyperglycemic period (induced with high-carbohydrate diet; diabetic subjects only) with serial blood and urine sampling.

Group II: Stage 1Experimental Treatment2 Interventions

Inpatient admission to NIH CC, consisting of euglycemic period with serial blood and urine sampling followed by hyperglycemic period (induced with high-carbohydrate diet; diabetic subjects only) with serial blood and urine sampling.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin E

2003

Completed Phase 4

~94880

Vitamin C

2017

Completed Phase 4

~18470