Cincinnati, Ohio 45229


Purpose:

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).


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

2014-6677


NCT ID:

NCT02462863


Secondary ID:


Study Acronym:


Brief Title:

Treatment of Type 2 Diabetes With Immunonutrients


Official Title:

Treatment of Type 2 Diabetes With Immunonutrients


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Christ Hospital


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:J. Wesley Alexander, M.D., Sc.D.
Principal Investigator
University of Cincinnati
Primary Contact:J. Wesley Alexander, M.D.,l Sc.D.
513-640-1268
jwesley.alexander@uc.edu
Backup Contact:Meenakshi Iyer, M.D.
513-267-1558
meenakshi.iyer@thechristhospital.com

Study Dates

Start Date:October 2015
Completion Date:July 2017
Completion Type:Anticipated
Primary Completion Date:July 2017
Primary Completion Type:Anticipated
Verification Date:July 2016
Last Changed Date:July 27, 2016
First Received Date:May 28, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Improvement of type 2 diabetes
Time Frame:6 months
Safety Issues:False
Description:Decrease in hemoglobin A1c and glucose.

Study Interventions

Intervention Type:Dietary Supplement
Name:Arginine and fish oil
Description:Dietary supplements
Arm Name:Immunonutrient treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Immunonutrient treatment
Description:Administration of arginine and fish oil.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Christ Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:Shriners Hospitals for Children

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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