NCT00362518

Brief Summary

The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and anti-oxidative atherosclerotic protection when administered at the optimal dose as determined by surrogate markers of inflammation, hypercoagulability, and oxidation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_3 diabetes

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

July 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

August 9, 2006

Last Update Submit

March 8, 2024

Conditions

Diabetes

Keywords

atherosclerosisvitamin Cvitamin E

Outcome Measures

Primary Outcomes (1)

  • The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes

    2 months

Secondary Outcomes (1)

  • To determine changes in surrogate markers of atherosclerosis in type 2 diabetes

    2 months

Study Arms (4)

1

PLACEBO COMPARATOR

Study Arm A - Control: no vitamins (placebo only).

Dietary Supplement: Study Arm A

2

ACTIVE COMPARATOR

Study Arm B - Low Dose: Vitamin C 250 mg, Vitamin E 200 IU

Dietary Supplement: Study Arm B

3

ACTIVE COMPARATOR

Study Arm C - Medium Dose: Vitamin C 500 mg, Vitamin E 400 IU

Dietary Supplement: Study Arm C

4

ACTIVE COMPARATOR

Study Arm D - High Dose: Vitamin C 1000 mg, Vitamin E 800 IU.

Dietary Supplement: Study Arm D

Interventions

Study Arm ADIETARY_SUPPLEMENT

Control: no vitamins (placebo only). This study will provide baseline metabolic and surrogate marker changes that are caused by the high fat meal. Study arms B, C, and D will be statistically compared to this study.

1
Study Arm BDIETARY_SUPPLEMENT

This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a low dosage form of vitamin C is administered (250 mg) and Vitamin E (200 IU).

2
Study Arm CDIETARY_SUPPLEMENT

This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a medium dosage form of vitamin C administered (500 mg)and Vitamin E (400 IU).

3
Study Arm DDIETARY_SUPPLEMENT

This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a high dosage form of vitamin C is administered (1000 mg) and Vitamin E (800 IU).

4

Eligibility Criteria

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

You may qualify if:

  • The study will enroll subjects, both men and women with type 2 diabetes of at least six months duration. The age of enrolled subjects will range from 21-60 years old. An HbA1c blood test must show that the person's diabetes is under control. Eligible subjects must have normal electrocardiogram tracings and normal hematological, electrolyte and liver laboratory results at screening. Females of childbearing age must agree to use an effective form of birth control throughout the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

  • Gutierrez AD, de Serna DG, Robinson I, Schade DS. The response of gamma vitamin E to varying dosages of alpha vitamin E plus vitamin C. Metabolism. 2009 Apr;58(4):469-78. doi: 10.1016/j.metabol.2008.11.003.

    PMID: 19303966DERIVED

MeSH Terms

Conditions

Diabetes MellitusAtherosclerosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • David S Schade, M.D.

    University of New Mexico School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 10, 2006

Study Start

July 1, 2004

Primary Completion

June 1, 2007

Study Completion

March 1, 2008

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

US(1)