Treatment of Type 2 Diabetes With Immunonutrients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Treatment of Type 2 Diabetes With Immunonutrients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462863
• Other study ID #: 2014-6677
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: June 7, 2017

Study information

• Verified date: September 2020
• Source: The Christ Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 7, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Arginine and fish oil
Dietary supplements

Locations

Country	Name	City	State
United States	J. Wesley Alexander, M.D., Sc.D.	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
The Christ Hospital	Shriners Hospitals for Children, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of type 2 diabetes	Decrease in hemoglobin A1c and glucose.	6 months