Treatment of Type 2 Diabetes With Immunonutrients

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

J. Wesley Alexander, M.D., Sc.D.

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arginine and fish oil

Dietary Supplement

Dietary supplements

Primary outcomes

Improvement of type 2 diabetes

Time frame: 6 months

Decrease in hemoglobin A1c and glucose.

Sponsors and collaborators

Lead sponsor

The Christ Hospital

Other

Collaborators

Shriners Hospitals for Children
University of Cincinnati

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 4, 2015
Registry last updated: Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed