Treatment of Type 2 Diabetes With Immunonutrients

Sponsor

The Christ Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02462863

Collaborator

Shriners Hospitals for Children (Other), University of Cincinnati (Other)

Enrollment

Location

Arm

15.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Arginine and fish oil	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

subjects will take arginine 4.5 grams BID plus Fish Oil 7 grams dailysubjects will take arginine 4.5 grams BID plus Fish Oil 7 grams daily

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Type 2 Diabetes With Immunonutrients

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

May 4, 2017

Actual Study Completion Date :

Jun 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immunonutrient treatment Administration of arginine and fish oil.	Dietary Supplement: Arginine and fish oil Dietary supplements

Arm

Intervention/Treatment

Experimental: Immunonutrient treatment

Administration of arginine and fish oil.

Dietary Supplement: Arginine and fish oil

Dietary supplements

Outcome Measures

Primary Outcome Measures

Improvement of type 2 diabetes [6 months]
Decrease in hemoglobin A1c and glucose.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.