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NCT00001870 · ClinicalTrials.gov registry record · Phase 2
Study of the Effects of Vitamin C on Patients With Type 2 Diabetes
A Phase 2 study of Diabetes Mellitus, Non-Insulin-Dependent and Non-Insulin Dependent, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT00001870: Completed Phase 2 study of Diabetes Mellitus, Non-Insulin-Dependent and Non-Insulin Dependent, sponsored by National Center for Complementary and Integrative Health (NCCIH).
NCT00001870 is a Phase 2 study of Diabetes Mellitus, Non-Insulin-Dependent and Non-Insulin Dependent that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 150 participants, below the 214-participant average among 5 other Diabetes Mellitus, Non-Insulin-Dependent trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001870, a Phase 2 study of Diabetes Mellitus, Non-Insulin-Dependent and Non-Insulin Dependent, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Diabetes is a disease characterized by decreased sensitivity to the action on insulin to promote sugar (glucose) use and blood vessel relaxation (vasodilation) in muscle. Insulin's ability to cause blood vessel relaxation is controlled, in part, by nitric oxide (NO). Nitric oxide is a substance produced by the cells lining blood vessel walls (endothelium). Increased blood flow to the muscle accounts for increased sugar (glucose) to areas of the body. Therefore, if the cells of blood vessel walls (endothelium) are not functioning properly it may contribute to insulin resistance. Injections of Vitamin C directly into the arteries have been shown to improve blood vessel reaction to nitric oxide in diabetic patients. Researchers believe this may be due to Vitamin C's ability to increase the levels of nitric oxide in blood vessels. The goal of this study is to determine the effects of vitamin C on both insulin sensitivity and endothelium function of patients with type 2 diabetes. An additional goal of the study is to determine the effects of vitamin C on patients with vitamin C deficiency. Patients participating in this study will undergo a series of testes to determine insulin sensitivity and blood vessel reactivity. Patients will be divided into two groups. One group will receive doses of oral vitamin C. The other group will receive doses of a placebo (inactive pill not containing vitamin C). Patients will receive the medications for four weeks and then be tested again for insulin sensitivity and blood vessel reactivity. Researchers believe that doses of vitamin C in diabetics or patients with vitamin C deficiency will improve insulin sensitivity and function of endothelium. Results gathered form this study may provide information about vitamin C levels in diabetics and may lead to the development of new therapies to treat insulin resistance and endothelium dysfunction.
Conditions Studied
Interventions
- DRUG Acetylcholine
Study Locations (1)
Maryland
- National Center for Complementary and Alternative Medicine (NCCAM) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 1999-01 |
| Est. Completion | 2004-12 |
| Phase | Phase 2 |
What the finished NCT00001870 record still lists
NCT00001870 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 214-participant average among 5 other Diabetes Mellitus, Non-Insulin-Dependent trials with a reported enrollment target (30% lower).
The record links to 2 conditions, with Diabetes Mellitus, Non-Insulin-Dependent appearing as the primary indexed condition, and to 1 intervention - of which Acetylcholine is the first listed.
NCT00001870 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001870 about?
NCT00001870 is a clinical study titled "Study of the Effects of Vitamin C on Patients With Type 2 Diabetes". Diabetes is a disease characterized by decreased sensitivity to the action on insulin to promote sugar (glucose) use and blood vessel relaxation (vasodilation) in muscle. Insulin's ability to cause blood vessel relaxation is controlled, in part, by nitric oxide (NO). Nitric oxide is a substance pro...
What is the current status of trial NCT00001870?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 1999-01. Estimated completion is 2004-12.
What conditions does trial NCT00001870 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Non-Insulin-Dependent, Non-Insulin Dependent.
What interventions are being tested in trial NCT00001870?
The interventions under investigation include: Acetylcholine (DRUG).
Who is sponsoring clinical trial NCT00001870?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001870 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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