Method and system to provide personalized pharmaceutical compositions and dosages
View Patent ↗Provided is a method for assessing cardiovascular risk in Metabolic Syndrome and Type 2 Diabetes patients. The method involves obtaining data from a Type 2 diabetes patient or a Metabolic Syndrome patient and determining a Fayad/Schentag index which includes a Glucose Supply Index (S) to an Insulin Demand Index (D) ratio. The Fayad/Schentag index is used in scoring cardiovascular risks of Metabolic Syndrome patients and for recommending and implementing therapeutic interventions that can be shown to lower cardiovascular risk.
1. A method for determining cardiovascular risk for an individual suspected of having, at risk for, or diagnosed with a Metabolic Syndrome, the method comprising:
a) obtaining from the individual one or more biological parameters, wherein the biological parameters are selected from the group consisting of fasting Blood Glucose, Triglycerides, Hemoglobin A1c, body mass index, Aspartate Transferase and fasting Blood Insulin, and from the biological parameters:
b) determining a Fayad/Schentag (FS) index, wherein the FS index is calculated as:
0.11
(
(
F
B
G
+
T
G
)
+
H
B
A
1
c
×
H
B
A
1
c
×
20
5
+
B
M
I
×
F
B
G
+
T
G
150
+
A
S
T
×
T
G
×
4
100
+
F
B
insulin
×
(
B
M
I
-
22
)
)
S
/
D
ratio
wherein the FBG is Fasting Blood Glucose in mg/dl; the TG is Triglycerides in mg/dl; the HBA1c is hemoglobin A1c in %; the BMI is body mass index in kg/m 2 ; AST is Aspartate Transferase in IU/liter; FB insulin is fasting Blood insulin concentration in nmol/liter; and the S/D ratio (SD) is a ratio of Glucose Supply Index (S) to Insulin Demand Index (D) calculated as follows:
(S) calculated as follows:
1+[aggregate of carbohydrate exposure(CE)+hepatic glucose uptake(HGU)+hepatic gluconeogenesis(GNG) and +insulin resistance(IR)],
and (D) calculated as follows:
1+[aggregate of peripheral glucose uptake(PGU)+peripheral insulin exposure(PIE)];
c) assign the FS index determined in b) to the individual, wherein the FS index is a value of greater than 60 and is thereby indicative that the individual is in need of therapy for Metabolic Syndrome or at risk for at least one cardiovascular complication associated with Metabolic Syndrome, the method further comprising:
d). administering to the individual a drug, wherein the drug is used to treat or resolve Metabolic Syndrome and is a formulation comprising pH encapsulated glucose, wherein said glucose from said pH encapsulated glucose formulation is targeted for release in the ileum of said individual, wherein conditions for release of said glucose from said pH encapsulated glucose formulation are a pH at or above a pH of 7.0.
2. The method of claim 1 , wherein the individual has been diagnosed with Metabolic Syndrome, wherein the individual is being treated for Metabolic Syndrome with at least one first drug known to be active against at least one component of the FS index, wherein the at least one first drug with which the individual is being treated is not the pH encapsulated glucose, and wherein the FS index value obtained in step b) is a first FS index value, the method further comprising prior to performing step d) repeating steps a), b) and c) after a period of time during which the individual continues treatment with the at least one first drug to provide a second FS index value, wherein a higher second FS index value relative to the first FS index value indicates that the individual is in need of a change in dosing of the at least one first drug, or a change to a different drug, or is a candidate for bariatric surgery, the method further comprising performing step d).
3. The method of claim 2 , wherein each FS index value is determined using a microprocessor.
4. The method of claim 2 , wherein the SD ratio is determined using a programmable spreadsheet.
5. The method of claim 1 , wherein at the time the determining the FS index value of greater than 60 is performed, the individual is not being treated with a diabetes drug, and wherein the SD ratio is 1.
6. The method of claim 1 , wherein the FS index value is determined using a microprocessor.
7. The method of claim 1 , wherein the SD ratio is determined using a programmable spreadsheet.
8. The method of claim 1 , wherein severity of one or more of the cardiovascular complications associated with Metabolic Syndrome is reduced subsequent to the administration of the formulation comprising pH-encapsulated glucose.
9. The method of claim 8 , wherein the glucose in said pH-encapsulated glucose formulation ranges from 5 grams to 20 grams.
10. The method of claim 1 , wherein the formulation comprising pH encapsulated glucose is administered in combination with an additional agent selected from the group consisting of anti-diabetes drugs, insulin, statin drugs, hormones, GLP-1 drugs, lipids, proteins, amino-acids, other sugars or carbohydrates, Metformin, Sitagliptin, and combinations thereof.