The investigator propose to test the safety and efficacy of a regimen that combines Omega-3 Fatty Acids and Vitamin D in a design that considers timing and duration of administration in relation to their effects and predicted synergies.
These agents may afford promote sustained immune regulation, reduce inflammation, and provide support for the residual beta cell mass. This integrated therapeutic regimen addresses major pathogenic mechanisms in T1D (Type 1 Diabetes) and thus represents a rational and well supported approach to preserve insulin secretion in T1D (Type 1 Diabetes). This approach could halt the disease progress, preserve β-cell function and hopefully reduce dose of insulin required to manage T1D (Type 1 Diabetes). The investigator hypothesizes that Omega-3 Fatty Acids and Vitamin D, administered to patients with newly or established T1D (Type 1 Diabetes) and residual stimulated C-peptide secretion will be safe and may preserve insulin secretion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Oral Administration
Oral Administration
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States
Change in MMTT (Mixed Meal Tolerance Test) 90 Min C-peptide
Stimulated (90-minute sample of a MMTT) C-peptide at the 1-year visit greater or equal to baseline level measured by ng/mL. Change in 90-minute C-peptide between baseline and 1-year visit
Time frame: Baseline and 1-Year Visit
Change in Hemoglobin A1c Level
Change in HbA1c between baseline and 1-year
Time frame: Baseline and 1-Year Visit
Change in Insulin Requirements
Difference in insulin requirement at the 1-year visit compared to baseline measured in units/kg/day
Time frame: Baseline and 1-Year Visit
Number of Adverse Events (AE)
Number of adverse events (AE) comparable to general diabetes population
Time frame: Through study completion, and average of one year
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