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Details for Patent: 5,760,047

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Details for Patent: 5,760,047

Title: Method for treatment of obesity using prolactin modulators and diet
Abstract:The present invention is directed to an improvement in a method of weight and/or body-fat reduction comprising a (preferably moderate) reduction in the caloric intake of a subject in need of such treatment in combination with administration to said subject of a prolactin inhibitor. Additionally, the present invention is directed to an improvement in a method for altering and/or resetting prolactin profiles (and thereby controlling one or more metabolic disorders such as obesity, excessive body fat, hyperlipidemia, hyperlipoproteinemia, hyperglycemia, hypercholesterolemia, hyperinsulinemia, insulin resistance, glucose intolerance, and Type II diabetes) comprising administration to a subject in need of such treatment of a prolactin inhibitor at a predetermined time or times during a 24-hour period in combination with a (preferably moderate) reduction of the caloric intake of said subject.
Inventor(s): Cincotta; Anthony H. (Andover, MA), Meier; Albert H. (Andover, MA)
Assignee: The Board of Supervisors of Louisiana State University and Agriculture (Baton Rouge, LA) Ergo Research Corporation (Wakefield, RI)
Filing Date:May 10, 1995
Application Number:08/438,650
Claims:1. A method for improving an aberrant metabolic index selected from the group consisting of hyperinsulinemia, hyperglycemia, hyperlipidemia, hypercholesterolemia, glucose intolerance, and insulin insensitivity in a patient in need of such treatment comprising in combination the steps of:

(a) administering daily to said patient a predetermined amount of a prolactin inhibitor at a first predetermined time during a 24-hour period prior to a time at which said patient's daytime prolactin level is higher than the corresponding normal daytime prolactin level by more than 1 SEM; and

(b) restricting said patient's daily caloric intake.

2. The method of claim 1 wherein said prolactin inhibitor is bromocriptine.

3. The method of claim 2 wherein said predetermined amount is within the range of 0.8 to 3.2 mg of bromocriptine.

4. The method of claim 1, wherein said prolactin administration and caloric intake restriction continue for a period of time from about 10 to about 180 days.

5. The method of claim 1 wherein said predetermined time is within the period from 0500 to 1300 hours.

6. The method of claim 1 wherein a second predetermined amount of a prolactin inhibitor is given to said patient at a second predetermined time wherein said second predetermined time is within the period from 900 to 1300 hours and said first predetermined time is within the period from 0500 to 1000 hours.

7. The method of claim 1 wherein said restriction in caloric intake is moderate.

8. The method of claim 1 wherein the caloric intake of said patient after said restriction is from 70 to 90% of the number of calories required by said patient for weight maintenance.

9. The method of claim 8 wherein the caloric intake of said patient after said is 70% of the number of calories required for weight maintenance, provided that the restricted caloric intake is not below 1200 calories per day.

10. The method of claim 1 wherein said metabolic index improvement persists for an extended period of time after cessation of said treatment.

11. A method for treating Type II diabetes in a patient in need of such treatment comprising in combination the steps of:

(a) administering daily to said patient a predetermined amount of a prolactin inhibitor at a first predetermined time during a 24-hour period prior to a time at which said patient's daytime prolactin level is higher than the corresponding normal daytime prolactin level by more than 1 SEM; and

(b) restricting said patient's daily caloric intake; thereby causing at least one benefit selected from the group consisting of reduction in hyperinsulinemia, reduction in hyperglycemia, improvement in glucose tolerance, reduction in glycosylated hemoglobin, and increase in insulin sensitivity.

12. The method of claim 11 wherein said prolactin inhibitor is bromocriptine.

13. The method of claim 12 wherein said predetermined amount is within the range of 0.8 to 3.2 mg of bromocriptine.

14. The method of claim 11 wherein said prolactin administration and caloric intake restriction continue for a period of time about 10 to about 180 days.

15. The method of claim 11 wherein said predetermined time is within the period from 0500 to 1300 hours.

16. The method of claim 11 wherein a second predetermined amount of a prolactin inhibitor is given to said patient at a second predetermined time wherein said second predetermined time is within the period from 300 to 1300 hours and said first predetermined time is within the period from 0500 to 1000 hours.

17. The method of claim 11 wherein said restriction in caloric intake is moderate.

18. The method of claim 11 wherein the caloric intake of said patient after said restriction is from 70 to 90% of the number of calories required by said patient for weight maintenance.

19. The method of claim 18 wherein the caloric intake of said patient after said is 70% of the number of calories required for weight maintenance, provided that the restricted caloric intake is not below 1200 calories per day.

20. The method of claim 11 wherein said benefit persists for an extended period of time after cessation of said treatment.

21. A method for improving an aberrant metabolic index selected from the group consisting of hyperinsulinemia, hyperglycemia, hyperlipidemia, hypercholesterolemia, glucose intolerance, and insulin insensitivity in a patient in need of such treatment comprising in combination the steps of:

(a) administering daily to said patient a predetermined amount of a prolactin inhibitor at a first predetermined time during a 24-hour period prior to a time at which said patient's daytime prolactin level is higher than the corresponding normal daytime prolactin level by more than 1 SEM; and

(b) restricting said patient's daily caloric intake;

said combination achieving an increased improvement of said metabolic index compared to that achieved by either step (a) or step (b) alone.
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