Treatment of Type 2 Diabetes With Immunonutrients

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Arginine and fish oil

• Registration Number: NCT02462863
• Lead Sponsor: The Christ Hospital

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).

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 Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Study Start: 2016-03-01
• Primary Completion: 2017-05-04
• Study Completion: 2017-06-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunonutrient treatment	Arginine and fish oil	Administration of arginine and fish oil.

Primary Outcome Measures

Name	Time	Method
Improvement of type 2 diabetes	6 months	Decrease in hemoglobin A1c and glucose.

Trial Locations

Locations (1)

J. Wesley Alexander, M.D., Sc.D.; 🇺🇸 Cincinnati, Ohio, United States