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Claims for Patent: 5,756,513

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Claims for Patent: 5,756,513

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 (Baton Rouge, LA)
Application Number:08/459,020
Patent Claims: 1. A process for therapeutically modifying and resetting the prolactin rhythm, or both the prolactin and glucocorticosteriod rhythms, in a human subject in need of treatment, which comprises

administering to the subject a dopamine agonist on a daily basis at a time of day between a time shortly after awakening until five hours after awakening, in dosage amount ranging from about 3 micrograms to about 40 micrograms, per pound of body weight, and continuing the treatments over a period sufficient to improve the sensitivity of the subject to insulin, suppress hyperinsulinemia or reduce hyperglycemia, or both suppress hyperinsulinemia and reduce hyperglycemia.

2. The process of claim 1 wherein the dosages of dopamine agonist are given over a period ranging from about 30 days to about 120 days.

3. The process of claim 1 wherein the dopamine agonist is administered daily to a subject at the time of day corresponding to that which will produce a plasma prolactin rhythm, or both prolactin and cortisol rhythms, that will peak as in an obese subject of the same species to increase the body fat content of the lean subject.

4. The process of claim 1 wherein the dopamine agonist is administered daily to the subject to increase the cellular sensitivity of the treated subject to the glucose disposal effects of insulin.

5. A method of claim 1 wherein the dopamine agonist is administered daily to the human subject to reduce at least one of body fat stores, insulin resistance, hyperglycemia, hyperinsulinemia, or blood levels of triglycerides.

6. The process of claim 1 wherein the dopamine agonist is administered daily to a subject to reduce hyperglycemia.

7. 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.

8. A method of claim 1, wherein said human subject is insulin resistant.

9. A method of claim 1, wherein said human subject is a diabetic.

10. A method of claim 9, wherein said human subject is a type II diabetic.

11. A method of claim 1, wherein said human subject is obese.

12. A method of claim 8, wherein the dopamine agonist is administered daily to said human subject to reduce at least one of body fat stores, insulin resistance, hyperglycemia, hyperinsulinemia, or blood levels of triglycerides.

13. A method of claim 9, wherein the dopamine agonist is administered daily to said human subject to reduce at least one of body fat stores, insulin resistance, hyperglycemia, hyperinsulinemia, or blood levels of triglycerides.

14. A method of claim 10, wherein the dopamine agonist is administered daily to said human subject to reduce at least one of body fat stores, insulin resistance, hyperglycemia, hyperinsulinemia, or blood levels of triglycerides.

15. A method of claim 11, wherein the dopamine agonist is administered daily to said human subject to reduce at least one of body fat stores, insulin resistance, hyperglycemia, hyperinsulinemia, or blood levels of triglycerides.

16. A method of claim 1, wherein said dopamine agonist is bromocriptine.

17. A method of claim 12, wherein said dopamine agonist is bromocriptine.

18. A method of claim 13, wherein said dopamine agonist is bromocriptine.

19. A method of claim 14, wherein said dopamine agonist is bromocriptine.

20. A method of claim 15, wherein said dopamine agonist is bromocriptine.
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