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Details for Patent: 5,635,512

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Details for Patent: 5,635,512

Title: Method for modifying or resetting the prolactin rhythm of an insulin insensitive or diabetic animal or human
Abstract:A process for the long term modification and regulation of linid 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 Business and Agricultural and (Baton Rouge, LA)
Filing Date:Jun 05, 1995
Application Number:08/460,858
Claims:1. A method for modifying or resetting the prolactin rhythm of an insulin insensitive or diabetic animal or human subject which comprises:

(a) administering to said subject a prolactin-inhibiting compound once a day, at a predetermined time within a 24-hour period; and

(b) additionally administering to said subject a prolactin-stimulating compound;

wherein each compound is administered in an amount sufficient, and for a period of time sufficient to accomplish at least one of the following: decrease insulin resistance, decrease hyperglycemia, decrease hyperinsulemia in said subject, and increase in glucose tolerance.

2. A method for modifying or resetting the prolactin rhythm of an insulin insensitive or diabetic animal or human subject comprising:

(a) administering to said subject a prolactin-inhibiting compound daily at a predetermined time of day designed to cause the daytime prolactin bloodstream level of said subject to decrease, thereby approaching the low daytime prolactin level of a lean, insulin sensitive subject; and

(b) administering to said subject a prolactin stimulating compound daily at a predetermined time of day designed to cause the nightime prolactin bloodstream level of said subject to increase thereby approaching the high nightime prolactin level of a lean, insulin sensitive subject;

wherein each compound is administered in a dosage amount sufficient and 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, improvement in glucose tolerance and reduction of hyperglycemia.

3. The method of claim 1 wherein the proactin-inhibiting compound is a dopamine agonist.

4. The method of claim 1 wherein said dosage amount of the dopamine agonist is within the range of about 3 to about 100 micrograms per pound of body weight of said subject and the dosage range of such prolactin stimulating compound is within the range of about 10 to about 100 micrograms per pound of body weight.

5. The method of claim 4 wherein on cessation of administration of both compounds the prolactin rhythm of the treated subject will correspond substantially, on a long-term basis, with that of a lean, insulin-sensitive subject.

6. The method of claim 3 wherein said period of administration of the dopamine agonist and prolactin stimulating compound is about 30 days to about 150 days.

7. The method of claim 3 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-aminoethyl-10 alpha-ergoline; 8-acylaminoergolenes; ergocornine; 9,10-dihydroergocornine; bromocriptine, and D-2-halo-6-alkyl-8-substituted ergolines.

8. The method of claim 2 wherein said prolactin-inhibiting compound is bromocriptine.

9. The method of claim 3 wherein said prolactin-inhibiting compound is bromocriptine.

10. The method of claim 4 wherein said prolactin-inhibiting compound is bromocriptine.

11. The method of claim 5 wherein said prolactin-inhibiting compound is bromocriptine.

12. The method of claim 6 wherein said prolactin-inhibiting compound is bromocriptine.

13. The method of claim 7 wherein said prolactin-inhibiting compound is bromocriptine.
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