NCT00534014

Brief Summary

Study Goal #1: Determine the optimal oral dose of vitamin C to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals. Study Goal #2: After conducting the original study, we found that vitamin E was not effective in reducing the markers of oxidative stress, hypercoagulation, inflammation, and metabolic parameters in patients with type 2 diabetes. To date, data from randomized trials have largely demonstrated no significant benefit of vitamin E supplementation on the prevention of primary and/or secondary cardiovascular disease as once thought. Therefore, we decided to amend our current protocol to add a Part B to study only the effects of vitamin C at the following doses: 500 mg, 1000 mg, and 2000 mg daily (and include a placebo arm, as well.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

September 20, 2007

Last Update Submit

March 8, 2024

Conditions

AtherosclerosisType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • To determine the optimal oral dose of vitamin C and E to reduce surrogate markers of atherosclerosis (blockages in blood vessels) following the consumption of an atherogenic high fat lunch in type 2 diabetic individuals.

    8 weeks

Secondary Outcomes (1)

  • To study the effects of vitamin C on fibrinogen, insulin, glucose, PAI-1, adiponectin, free MDA, Oxy LDL,CRP, cholesterol, and FFA.

    8 weeks

Study Arms (4)

A

PLACEBO COMPARATOR

0 mg of Vitamin C

Dietary Supplement: Vitamin C

B

ACTIVE COMPARATOR

250 mg Vitamin C

Dietary Supplement: Vitamin C

C

ACTIVE COMPARATOR

500 mg Vitamin C

Dietary Supplement: Vitamin C

D

ACTIVE COMPARATOR

1000 mg Vitamin C

Dietary Supplement: Vitamin C

Interventions

Vitamin CDIETARY_SUPPLEMENT

Arm A = 0 mg Vitamin C, Arm B = 250 mg Vitamin C, Arm C = 500 mg Vitamin C, Arm D = 1000 mg Vitamin C

ABCD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic for at lease 6 months
  • Body mass index less than 40kg/m2
  • Normal EEG's
  • Normal test results from screening visit.

You may not qualify if:

  • Known vascular disease
  • Uncontrolled hypertension (\>140/90 mmHg) or marked hyperlipidemia (serum low denisity lipoprotein \>4.1 mmol/L or serum triglycerides \> 7.8 mmol/L)
  • Pregnancy
  • Cigarette smoking
  • Currently taking coumadin
  • Recent use of antioxidant supplements or asprin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico , Clinical Translational Science Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

  • Gutierrez AD, Duran-Valdez E, Robinson I, de Serna DG, Schade DS. Does short-term vitamin C reduce cardiovascular risk in type 2 diabetes? Endocr Pract. 2013 Sep-Oct;19(5):785-91. doi: 10.4158/EP12431.OR.

    PMID: 23757614DERIVED

MeSH Terms

Conditions

AtherosclerosisDiabetes Mellitus, Type 2

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • David S Schade, M.D.

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2007

Study Completion

May 1, 2007

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

US(1)