NCT02462863

Treatment of Type 2 Diabetes With Immunonutrients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The Christ Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Arginine and fish oil	Dietary supplements

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-04
• Completion: 2017-06-07
• First posted: 2015-06-04
• Last updated: 2020-10-01

Locations

1 site across 1 country: United States