Treatment of Type 2 Diabetes With Immunonutrients

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT02462863

Run by

The Christ Hospital

People needed

6

Starts

2016-03-01

Expected to finish

2017-06-07

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Chronic infection, past history of cancer except cured skin cancer. Active inflammation processes will also be excluded. Pregnant or nursing women will be excluded.

Where it is running

• J. Wesley Alexander, M.D., Sc.D. — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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