Methods and compositions for the treatment of pre-diabetes, diabetes and metabolic syndrome

Abstract

The disclosure provides thiol-containing alkyl fatty acid and vitamin D compound formulations for intra-venous, parenteral or oral administration. The compositions of the present technology have optimal controlled bioavailability and are useful for treating metabolic dysfunctions such as pre-diabetes, Metabolic Syndrome and diabetes. Also provided are methods of treatment comprising the daily administration of the disclosed thiol-containing alkyl fatty acid formulations alone or in combination with the disclosed vitamin D compound formulations.

1 .- 37 . (canceled) 
     
     
         38 . A method for reducing HbA1c levels in a mammalian patient in need thereof, the method comprising:
 administering to the patient a therapeutically effective amount of a composition comprising a thiol-containing alkyl fatty acid formulation configured to reduce HbA1c levels in mammalian subjects, the thiol-containing alkyl fatty acid formulation comprising:
 alpha-lipoic acid, L-carnitine, CoQ10, L-glutamine, and L-arginine. 
   
     
     
         39 . The method of  claim 38 , wherein the thiol-containing alkyl fatty acid formulation comprises 600 mg alpha-lipoic acid, 400 mg L-carnitine, 100 mg CoQ10, 750 mg L-glutamine, and 1500 mg L-arginine. 
     
     
         40 . The method of  claim 38 , wherein the alpha-lipoic acid is present as a mixture of R and S isomers. 
     
     
         41 . The method of  claim 38 , wherein the mammalian patient is suffering from a metabolic dysfunction, and wherein the metabolic dysfunction is metabolic syndrome, pre-diabetes, or diabetes. 
     
     
         42 . The method of  claim 38 , wherein the composition comprising the thiol-containing alkyl fatty acid formulation is administered orally or intravenously. 
     
     
         43 . The method of  claim 38 , wherein the mammalian patient, prior to administration of the composition, has an HbA1c level of 5.7% or greater. 
     
     
         44 . The method of  claim 38 , wherein the alpha-lipoic acid, L-carnitine, CoQ10, L-glutamine, and L-arginine are active ingredients. 
     
     
         45 . The method of  claim 44 , wherein the composition further comprises pharmaceutically acceptable carriers and excipients. 
     
     
         46 . The method of  claim 38 , wherein the composition is administered daily for one week or more. 
     
     
         47 . The method of  claim 38 , wherein the composition is administered one, two, three, four, or five times per day. 
     
     
         48 . The method of  claim 38 , wherein the composition is administered weekly, bi-weekly, tri-weekly, or monthly. 
     
     
         49 . The method of  claim 38 , wherein the mammalian patient is human. 
     
     
         50 . A thiol-containing alkyl fatty acid formulation for reducing HbA1c levels in mammalian subjects in need thereof comprising alpha-lipoic acid, L-carnitine, CoQ10, L-glutamine, and L-arginine as active ingredients and at least one pharmaceutically acceptable carrier or excipient. 
     
     
         51 . The thiol-containing alkyl fatty acid formulation of  claim 50 , further comprising a buffer. 
     
     
         52 . The thiol-containing alkyl fatty acid formulation of  claim 51 , wherein the buffer minimizes rapid degradation, increases absorption of the formulation, and/or minimizes stomach irritation or acid reflux. 
     
     
         53 . The thiol-containing alkyl fatty acid formulation of  claim 51 , wherein the buffer including ion-pairing salts. 
     
     
         54 . The thiol-containing alkyl fatty acid formulation of  claim 50 , wherein:
 the alpha-lipoic acid is present from about 5 wt % to about 20 wt % of the formulation;   the L-carnitine is present from about 5 wt % to about 20 wt % of the formulation;   the CoQ10 is present from about 1 wt % to about 5 wt % of the formulation;   the L-glutamine is present from about 20 wt % to about 30 wt % of the formulation; and   the L-arginine is present from at least about 31 wt % to about 65 wt % of the formulation.   
     
     
         55 . The thiol-containing alkyl fatty acid formulation of  claim 50 , wherein:
 the alpha-lipoic acid is present from about 600 mg to about 800 mg;   the L-carnitine is present from about 400 mg to about 450 mg;   the CoQ10 is present from about 100 mg to about 150 mg;   the L-glutamine is present from about 600 mg to about 800 mg; and   the L-arginine is present from about 1400 mg to about 1600 mg.   
     
     
         56 . The thiol-containing alkyl fatty acid formulation of  claim 50 , wherein:
 a ratio of the alpha-lipoic acid to the L-carnitine in the formulation is between about 2.1:1 and about 1.1:1;   a ratio of the alpha-lipoic acid to the CoQ10 in the formulation is between about 8:1 and about 3:1;   a ratio of the alpha-lipoic acid to the L-glutamine in the formulation is between about 1:1 to about 1:3; and   a ratio of the alpha-lipoic acid to the L-arginine in the formulation is between about 1:1 to about 1:3.   
     
     
         57 . A method of reducing HbA1c levels in a patient comprising administering a therapeutically effective amount of the thiol-containing alkyl fatty acid formulation of  claim 50 .