Prevention of hyperinsulinemia in subjects undergoing growth hormone (GH) treatment

Abstract

The present invention provides methods and compositions for preventing hyperinsulinemia that can result from therapeutic administration of growth hormone. The methods are carried out by imposing a restricted high-fat diet and/or by administering one or more drugs that lower serum lipids.

1 . A method for preventing hyperinsulinemia in an animal or human subject undergoing treatment with growth hormone (GH), the method comprising subjecting said subject, during the growth hormone treatment period, to a measure that causes a reduction in blood lipid levels.  
     
     
         2 . A method according to  claim 1 , wherein said measure is selected from the group consisting of a diet regimen, a drug treatment, or a combination thereof.  
     
     
         3 . A method according to  claim 2 , wherein the diet regimen comprises a restricted amount of a high-fat (HF) diet as a sole food source.  
     
     
         4 . A method according to  claim 3 , wherein the energy content of the diet does not exceed the theoretical maintenance level for the subject.  
     
     
         5 . A method according to  claim 2 , wherein the drug treatment comprises administering a compound selected from the group consisting of: 5-methylpyrazinecarboxylic acid 4-oxide, a statin, a fibrate, or a combination of any of the foregoing, wherein said administering is effective in reducing blood lipid levels in the subject.  
     
     
         6 . A method according to  claim 1 , wherein the subject is a human.  
     
     
         7 . A method according to  claim 6 , wherein the human is obese.  
     
     
         8 . A method for catabolizing adipose tissue in an animal or human subject without induction of hyperinsulinemia, the method comprising (i) administering a growth hormone (GH) to the subject and (ii) subjecting the subject to a measure that causes a reduction in blood lipid levels.  
     
     
         9 . A method according to  claim 8 , wherein said measure is selected from the group consisting of a diet regimen, a drug treatment, or a combination thereof.  
     
     
         10 . A method according to  claim 9 , wherein the diet regimen comprises a restricted amount of a high-fat (HF) diet as a sole food source.  
     
     
         11 . A method according to  claim 10 , wherein the energy content of the diet does not exceed the theoretical maintenance level for the subject.  
     
     
         12 . A method according to  claim 9 , wherein the drug treatment comprises administering a compound selected from the group consisting of: 5-methylpyrazinecarboxylic acid 4-oxide, a statin, a fibrate, or a combination of any of the foregoing, wherein said administering is effective in reducing blood lipid levels in the subject.  
     
     
         13 . A method for reducing blood lipid levels in an animal or human subject without induction of hyperinsulinemia in the subject, the method comprising (i) administering a growth hormone (GH) to the subject and (ii) providing said subject with restricted amounts of a high-fat (HF) diet as a sole food source.  
     
     
         14 . A method for reducing blood lipid levels in an animal or human subject without induction of hyperinsulinemia in the subject, the method comprising (i) administering a growth hormone (GH) to said subject and (ii) inhibiting lipolysis in said subject.  
     
     
         15 . A pharmaceutical composition comprising, as active ingredients, (i) a growth hormone and (ii) an agent capable of reducing blood lipid levels.  
     
     
         16 . A pharmaceutical composition comprising, as active ingredients, (i) a growth hormone and (ii) a lipolysis-inhibiting agent.  
     
     
         17 . A pharmaceutical composition according to  claim 16 , wherein said agent is an HSL inhibitor.  
     
     
         18 . A medical kit comprising (i) a growth hormone preparation and (ii) one or more agents capable of causing a reduction in blood lipid levels.  
     
     
         19 . A medical kit according to  claim 18 , wherein said agent (ii) is a lipolysis-inhibiting agent.  
     
     
         20 . A medical kit according to  claim 19 , wherein said lipolysis-inhibiting agent is an HSL inhibitor.