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Study of the Effects of Vitamin C on Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001870
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: December 2004
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin Dependent
Non-Insulin Dependent
Drug: Acetylcholine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Effects of Oral Vitamin C Administration on Insulin Sensitivity and Vascular Reactivity in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: January 1999
Estimated Study Completion Date: December 2004
Detailed Description:

Diabetes is characterized by decreased sensitivity to the actions of insulin to promote both glucose utilization and vasodilation in skeletal muscle beds. Insulin's vasodilator action is mediated, in part, by endothelial-derived nitric oxide (NO). Increased blood flow accounts for approximately 25% of the increase in skeletal muscle glucose disposal mediated by insulin. Therefore, endothelial dysfunction may contribute to insulin resistance. Intraarterial administration of vitamin C improves NO-dependent vascular reactivity in diabetic subjects (but not normal subjects). This may be due to antioxidant properties of vitamin C that result in relative increases in the level of NO in the diabetic vasculature. In this exploratory protocol, our primary objective is to assess the effects of oral administration of vitamin C on both insulin sensitivity and endothelial function in subjects with type 2 diabetes. A secondary, peripheral objective, is to study these effects in vitamin C-deficient clinical research volunteers. Hyperinsulinemic euglycemic glucose clamp procedures and forearm blood flow measurements will be used to assess both insulin sensitivity and vascular reactivity in diabetic subjects and clinical research volunteers who have plasma vitamin C levels less than 30 microM. The subjects will then be given either placebo or oral vitamin C supplementation (800 mg/day) for four weeks and assessment of insulin sensitivity and vascular reactivity will be repeated. Plasma levels of vitamin C will be measured to confirm that subjects in the experimental group have an appropriate increase in vitamin C levels. We hypothesize that chronic oral administration of vitamin C to diabetic or clinical research volunteers who are deficient in vitamin C will improve insulin sensitivity and endothelial function. Our study will provide information about vitamin C levels in diabetic subjects and may suggest a potential therapy to significantly improve endothelial dysfunction and insulin resistance.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

DIABETIC SUBJECTS:

Males and non-pregnant females between the ages of 18 and 65 in good general health except for type 2 diabetes controlled with diet and/or oral hypoglycemic agents.

Patients found to have plasma vitamin C levels less than 40 microliter M, will be enrolled into the protocol and taken off hypoglycemic agents approximately one week prior to each study.

VITAMIN C-DEFICIENT CLINICAL RESEARCH VOLUNTEERS:

Adults between the ages of 18 and 35 in good general health and on no drugs or medications.

EXCLUSION CRITERIA:

ALL SUBJECTS:

Pregnancy, liver disease, pulmonary disease, renal insufficiency, coronary heart disease, heart failure, peripheral vascular disease, coagulopathy, disease predisposing to vasculitis or Raynaud's phenomenon, bleeding disorders, kidney stones, glucose-6-phosphate dehydrogenase deficiency, family history of hemochromatosis/iron overload, platelet count less than 150,000/ml blood, prothrombin time/partial thromboplastin time (PT/PTT) greater than 1 second above the normal range, inability to give informed consent for all procedures, and positive tests for HIV, or hepatitis B or C.

DIABETIC SUBJECTS:

In addition, to the above exclusion criteria, the presence of proteinuria greater than 500 mg/24 hrs, proliferative retinipathy, or diabetic neuropathy

VITAMIN C-DEFICIENT CLINICAL RESEARCH VOLUNTEERS:

All the above exclusion criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001870

Locations
United States, Maryland
National Center for Complementary and Alternative Medicine (NCCAM)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001870     History of Changes
Other Study ID Numbers: 990033, 99-AT-0033
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Insulin Resistance
Oxidative Stress
Antioxidant
Endothelial Function
Glucose Clamp
Type 2 Diabetes
Vitamin C Deficiency

Additional relevant MeSH terms:
Vitamins
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acetylcholine
Ascorbic Acid
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Protective Agents
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014