Clinical trial NCT02462863: Treatment of Type 2 Diabetes With Immunonutrients
Official title: Treatment of Type 2 Diabetes With Immunonutrients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
fish oil
arginine
hyperglycemia
Lead sponsor: The Christ Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
name: University of Cincinnati
First posted: 2015-06-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: subjects will take arginine 4.5 grams BID plus Fish Oil 7 grams daily
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Improvement of type 2 diabetes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: J. Wesley Alexander, M.D., Sc.D.
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: J. Wesley Alexander, M.D., Sc.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Christ Hospital
name: Meenakshi Iyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: