Treatment of Type 2 Diabetes With Immunonutrients
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/29/2016 |
| Start Date: | October 2015 |
| End Date: | July 2017 |
| Contact: | J. Wesley Alexander, M.D.,l Sc.D. |
| Email: | jwesley.alexander@uc.edu |
| Phone: | 513-640-1268 |
The purpose of this research study is to determine if the nutrients arginine and fish oil
will reverse or improve diabetes and to find out what additional good or bad effects a
combination of arginine and fish oil may have. Both arginine and fish oil are common
nutrients taken by normal people on a frequent basis. However, they have not been used in
combination in the proposed doses to reverse diabetes once it is established. This study has
been approved by the Food and Drug Administration (FDA investigational new drug [IND]
12191).
will reverse or improve diabetes and to find out what additional good or bad effects a
combination of arginine and fish oil may have. Both arginine and fish oil are common
nutrients taken by normal people on a frequent basis. However, they have not been used in
combination in the proposed doses to reverse diabetes once it is established. This study has
been approved by the Food and Drug Administration (FDA investigational new drug [IND]
12191).
The hypothesis for the proposed studies is that selected immunonutrients will reduce glucose
levels in type 2 diabetes and provide the basis for safe and effective treatment. This
should result in an increased resistance to infection, decrease in cardiovascular disease
and improve mortality as will be shown in subsequent studies.
Specific Aim 1: To demonstrate proof of concept that supplementation of a normal (diabetic)
diet with oral arginine and fish oil will reverse or at least improve glucose control, and
improve hemoglobin A1c (HgA1c) in patients with type 2 diabetes.
Specific Aim 2: To determine the relationship of plasma amino acid profiles and
concentration of selected fatty acids in cellular (RBC) membranes to the resolution of type
2 diabetes.
levels in type 2 diabetes and provide the basis for safe and effective treatment. This
should result in an increased resistance to infection, decrease in cardiovascular disease
and improve mortality as will be shown in subsequent studies.
Specific Aim 1: To demonstrate proof of concept that supplementation of a normal (diabetic)
diet with oral arginine and fish oil will reverse or at least improve glucose control, and
improve hemoglobin A1c (HgA1c) in patients with type 2 diabetes.
Specific Aim 2: To determine the relationship of plasma amino acid profiles and
concentration of selected fatty acids in cellular (RBC) membranes to the resolution of type
2 diabetes.
Inclusion Criteria:
- Adult onset diabetics, BMI under 35 with stable glycemic and hypertensive control.
Must be receiving medication for diabetes, be free of cardiac problems such as
myocardial infarction, atrial fibrillation or flutter, severe hepatic or
gastrointestinal disease, and have a glomerular filtration rate (GFR) of greater than
50 ml/minute. Must have an LDL-C of less than 120 mg/ml with or without treatment.
Exclusion Criteria:
- Chronic infection, past history of cancer except cured skin cancer. Active
inflammation processes will also be excluded. Pregnant or nursing women will be
excluded.
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