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Details for Patent: 5,654,313

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Details for Patent: 5,654,313

Title: Method for modifying or regulating the glucose metabolism of an animal or human subject
Abstract:A process for the long term modification and regulation of lipid and glucose metabolism--generally to reduce obesity, insulin resistance, and hyperinsulinemia or hyperglycemia, or both (these being the hallmarks of noninsulin dependent, or Type II diabetes)--by administration to a vertebrate, animal or human, of a dopamine agonist and a prolactin stimulator. The dopamine agonist and prolactin stimulator are administered in daily dosages, respectively, at a time of day dependent on the normal circadian rhythm of fat and lean members of a similar species. Decreases in body fat deposits result by treatment of an obese species on a daily timed sequence based on circadian rhythms of the peak prolactin, or peak prolactin and peak glucocorticosteroid, blood level established for lean insulin sensitive members of a similar species. The dopamine agonist is administered at the time of, or just after the time of peak plasma prolactin concentration found in lean animals of the same species and the prolactin stimulator is administered at a time just before the plasma prolactin rhythm reaches its peak in lean animals. Insulin resistance, and hyperinsulinemia or hyperglycemia, or both, can also be controlled in humans on a long term basis by treatment corresponding to that of the treatment for obesity. The short term daily injections reset hormonal timing in the neural centers of the brain to produce long term effects.
Inventor(s): Cincotta; Anthony H. (Andover, MA), Meier; Albert H. (Baton Rouge, LA)
Assignee: Ergo Science Incorporated (Charlestown, MA) Board of Supervisors of Louisiana University and Agricultural and (Baton Rouge, LA)
Filing Date:Jun 06, 1995
Application Number:08/465,674
Claims:1. A method for modifying or regulating the glucose metabolism of a human subject exhibiting at least one of the pathologies characteristically associated with Type II diabetes comprising:

(a) administering a prolactin-inhibiting compound to said subject daily at a time from about 1 hour to about 10 hours after the time at which the prolactin bloodstream level peaks in a lean member of the same species as said subject wherein said member is not exhibiting any of said pathologies associated with Type II diabetes, in a dosage amount within the range from about 3 micrograms to about 100 micrograms per pound body weight of said subject; and

(b) administering a prolactin-stimulating compound daily to said subject at a time from about two hours to about four hours prior to the time at which the prolactin bloodstream level peaks in a lean member of the same species sex as said subject, wherein said member is not exhibiting any of said pathologies associated with Type II diabetes, in a dosage amount within the range from about 10 micrograms to about 100 micrograms per pound body weight, wherein each compound is administered for a period of time sufficient to achieve in said subject at least one of the following modifications in glucose metabolism: decrease in insulin resistance, reduction of hyperinsulinemia, and reduction of hyperglycemia.

2. The method of claim 1 wherein the prolactin-inhibiting compound is a dopamine agonist.

3. The method of claim 2 wherein at least one modification persists over a long term after cessation of administration of the dopamine agonist and prolactin stimulating compound.

4. The method of claim 2 wherein the period of administration of said dopamine agonist and prolactin stimulating compound is sufficient to modify and reset the neural phase oscillations controlling at least one of the prolactin and glucocorticosteroid bloodstream levels of said subject.

5. The method of claim 2 wherein the compound is selected from the group consisting of 6-methyl-8-beta-carbobenzyloxy-aminoethyl-10 alpha-ergoline; 1,6-dimethyl-8-beta-carbobenzyloxy-aminoethyl-10 alpha-ergoline; 8-acylaminoergolenes; ergocomine; 9,10-dihydroergocomine; bromocriptine, and D-2-halo-6-alkyl-8-substituted ergolines.

6. The method of claim 1 wherein said dopamine agonist is bromocriptine.

7. The method of claim 2 wherein said dopamine agonist is bromocriptine.

8. The method of claim 3 wherein said dopamine agonist is bromocriptine.

9. The method of claim 4 wherein said dopamine agonist is bromocriptine.

10. The method of claim 5 wherein said dopamine agonist is bromocriptine.

11. The method of claim 1 wherein said prolactin stimulating compound is metoclopramide.

12. The method of claim 2 wherein said prolactin stimulating compound is metoclopramide.

13. The method of claim 3 wherein said prolactin stimulating compound is metoclopramide.

14. The method of claim 4 wherein said prolactin stimulating compound is metoclopramide.

15. The method of claim 5 wherein said prolactin stimulating compound is metoclopromide.

16. The method of claim 1 wherein said prolactin stimulating compound is 5-hydroxy-tryptophan.

17. The method of claim 2 wherein said prolactin stimulating compound is 5-hydroxy-tryptophan.

18. The method of claim 3 wherein said prolactin stimulating compound is 5-hydroxy-tryptophan.

19. The method of claim 4 wherein said prolactin stimulating compound is 5-hydroxy-tryptophan.

20. The method of claim 5 wherein said prolactin stimulating compound is 5-hydroxy-tryptophan.

21. A method for modifying or regulating glucose metabolism in an animal or human subject in need of such treatment comprising:

(a) administering to said subject a prolactin-inhibiting compound at a first predetermined time; and

(b) administering to said subject a prolactin stimulating compound daily at a second predetermined time; wherein said compounds are administered in dosage amounts and for a period of time sufficient to achieve in said subject at least one of the following modifications: decrease in insulin resistance, reduction of hyperinsulinemia, increase in glucose tolerance, and reduction of hyperglycemia.

22. The method of claim 21 wherein the prolactin-inhibiting compound is a dopamine agonist.

23. The method of claim 21 wherein at least one of said modifications persists on a long term basis after cessation of administration of said dopamine agonist and prolactin stimulating compound.

24. The method of claim 22 wherein said prolactin inhibiting compound is administered once a day at a dosage amount within the range from about 3 micrograms to about 100 micrograms per pound of body weight of said subject and the prolactin stimulating compound is administered once a day at a dosage amount within the range from about 10 micrograms to about 100 micrograms per pound of body weight of said subject.

25. The method of claim 22 wherein said subject is a human and said dosage amount for the dopamine agonist is within the range from about 3 micrograms to about 100 micrograms per pound body weight of said subject and the dosage amount for the prolactin stimulating compound is within the range from about 10 micrograms to about 100 micrograms per pound of body weight of said subject.

26. The method of claim 25 wherein said human subject exhibits at least one of insulin resistance and Type II diabetes and the dopamine agonist is administered once a day, at a time from 2 hours to about 8 hours after the time at which the prolactin plasma level peaks in a lean, insulin sensitive human and said prolactin-stimulating compound is administered at a time at least about 2 hours prior to the time at which the prolactin plasma level peaks in a lean, insulin sensitive human.

27. The method of claim 22 wherein the prolactin inhibiting dopamine agonist compound is selected from a group consisting of 6-methyl-8-beta-carbobenzyloxy-aminoethyl-10 alpha-ergoline; 1,6-dimethyl-8-beta-carbobenzyloxy-aminoethyl-10 alpha-ergoline; 8-acylaminoergolenes, ergocornine; 9,10-dihydroergocornine; bromocriptine, and D-2-halo-6-alkyl-8-substituted ergolines.

28. The method of claim 22 wherein the prolactin stimulating compound is selected from the group consisting of metoclopramide, haloperidol, pimozide, phenothiazine, sulpiride, chlorpromazine, and serotonin agonists.

29. The method of any one of claims 21-28 wherein the dopamine agonist is bromocriptine.

30. The method of any one of claims of 21-28 wherein the prolactin inhibiting compound is metoclopramide.

31. The method of any one of claims of 21-28 wherein the prolactin stimulating compound is 5-hydroxy-tryptophan.

32. The method of claim 28 wherein the prolactin stimulating compound is 5-hydroxy-tryptophan.
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