Treatment of Type 2 Diabetes With Immunonutrients

NCT02462863 | Completed

• 1 other identifier: 2014-6677
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; fish oil; arginine; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Improvement of type 2 diabetes

  Decrease in hemoglobin A1c and glucose.

  6 months

Study Arms (1)

Immunonutrient treatment

EXPERIMENTAL

Administration of arginine and fish oil.

Dietary Supplement: Arginine and fish oil

Interventions

Arginine and fish oil DIETARY_SUPPLEMENT

Dietary supplements

Immunonutrient treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Christ Hospital: lead
• Shriners Hospitals for Children: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

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

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia

Interventions

Arginine; Fish Oils

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Oils; Lipids

Study Officials

• J. Wesley Alexander, M.D., Sc.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Meenakshi Iyer, M.D.

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: subjects will take arginine 4.5 grams BID plus Fish Oil 7 grams daily

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 4, 2015
• Study Start: March 1, 2016
• Primary Completion: May 4, 2017
• Study Completion: June 7, 2017
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

US (1)