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Claims for Patent: 5,866,584

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Claims for Patent: 5,866,584

Title: Therapeutic process for the treatment of the pathologies of type II diabetes
Abstract:A process for the long term modification and regulation of lipid and carbohydrate metabolism--generally to reduce obesity, insulin resistance, and hyperinsulinemia or hyperglycemia, or both (these are the hallmarks of noninsulin dependent, or Type II diabetes)--by administration (i.e., by oral, sublingual or parenternal administration) to a vertebrate, animal or human, of a dopamine agonist, e.g., bromocriptine. Administration of the bromocriptine is made over a limited period at a time of day dependent on the normal circadian rhythm of insulin resistant and insulin sensitive members of a similar species. Insulin resistance, and hyperinsulinemia and hyperglycemia, or both, can be controlled in humans on a long term basis by such treatment inasmuch as the short term, daily administration resets 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: The Board of Supervisors of Louisiana State University and Agricultural and Mechanical College (Baton Rouge, LA)
Application Number:08/465,818
Patent Claims: 1. A process for the therapeutic modification and regulation of lipid metabolism in an animal, or human subject, which comprises administering to a subject in need of treatment, on a timed daily basis a dopamine agonist in dosage amount and for a period sufficient to reduce plasma triglyceride levels in said animal or human subject.

2. The process of claim 1 wherein after discontinuing treatment with the dopamine agonist the effects of the treatment continue for at least one month.

3. The process of claim 1 wherein the dopamine agonist administered on a timed daily basis to said subject is sufficient to modify or reset both the prolactin and glucocorticosteriod rhythms.

4. The process of claim 1 wherein the timed daily dosages of the dopamine agonist are given daily, once a day, over a period ranging from about 10 days to about 150 days, at levels ranging from about 3 micrograms to about 100 micrograms, per pound of body weight.

5. The process of claim 1 wherein the timed daily dosages of the dopamine agonist are given daily in amount ranging from about 3 micrograms to about 40 micrograms, per pound of body weight, in treating humans, over a period of from about 10 days to about 150 days.

6. The process of claim 5 wherein the dosage is given in amount ranging from about 3 micrograms to about 20 micrograms, per pound of body weight, over a period ranging from about 30 days to about 120 days.

7. The process of claim 5 wherein said subject is a human and the dopamine agonist is given daily at times ranging from about 1 hour to about 8 hours after the time corresponding to that in which the prolactin concentration peaks in a lean insulin sensitive person.

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

9. A process for the modification and regulation of lipid metabolism in a human subject in need of treatment which comprises administering to the subject, over a period ranging from about 30 days to about 120 days, at levels ranging from about 3 micrograms to about 40 micrograms, per pound of body weight, daily doses of a dopamine agonist at from about 1 to about 10 hours after the normal time of day that the prolactin level is at its peak-in a lean insulin-sensitive subject of the same species and sex, to produce a change of the neuroendocrine system of the subject to mimic that of the lean subject such that plasma triglyceride levels are reduced in said subject in need of treatment.

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

11. In a method for treating a vertebrate exhibiting one or more of obesity, insulin resistance, hyperinsulinemia, glucose intolerance, or hyperglycemia by delivery to said vertebrate of a prolactin inhibitor, the improvement which comprises:

confining the delivery of said prolactin inhibitor to the period during the day proximate to the time of day at which the serum prolactin concentration of a lean, insulin-sensitive vertebrate of the same sex and species is low.

12. A method for treating an animal exhibiting one or more of obesity, insulin resistance, hyperinsulinemia, glucose intolerance, or hyperglycemia, comprising:

administering to said animal a therapeutically effective amount of a prolactin inhibitor in a dosage regimen under which the delivery of said prolactin inhibitor is confined to the period during the day proximate to the time of day at which the serum prolactin concentration of a young, lean, insulin-sensitive animal of the same sex and species is low.

13. A method according to claim 11 in which the delivery of said prolactin inhibitor is confined to from about 4 to about 8 hours after the time of day of said peak concentration.

14. A method according to claim 12 in which the delivery of said prolactin inhibitor is confined to from about 4 to about 8 hours after the time of day of said peak concentration.

15. A method according to claim 13 in which said prolactin inhibitor is bromocriptine.

16. A method according to claim 14 in which said prolactin inhibitor is bromocriptine.

17. A method according to claim 15 wherein said bromocriptine is administered in an amount between about 3 and about 40 micrograms per pound of body weight per day.

18. A method according to claim 16 wherein said bromocriptine is administered in an amount between about 3 and about 40 micrograms per pound of body weight per day.

19. The method of claim 11 wherein said prolactin inhibitor is administered daily for at least 10 days.

20. The method of claim 12 wherein said prolactin inhibitor is administered daily for at least 10 days.

21. The method of claim 11 wherein said vertebrate is a human.

22. The method of claim 12 wherein said vertebrate is a human.

23. The method of claim 19 wherein said animal is a human.

24. The method of claim 20 wherein said animal is a human.

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

administering to said subject a prolactin inhibiting compound on a timed daily basis in a dosage amount and for a period 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, wherein said prolactin inhibitor is administered daily for at least 10 days.
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