Use of leptin for treating human lipoatrophy and method for determining predisposition to said treatment

Abstract

Leptin, leptin analogs, and leptin derivatives are used to treat patients with lipoatrophy. Leptin is effective against conditions of lipoatrophy for both genetic and acquired forms of the disease. A therapeutically effective amount of leptin can be administered in a variety of ways, including subcutaneously and using gene therapy methods. Methods of the present invention contemplate administration of leptin, leptin analogs, and leptin derivatives to patients having a leptin level of approximately 4 ng/ml or less before treatment.

1 - 32 . (canceled) 
     
     
         33 . A method of treating a metabolic disorder in a human patient with generalized lipodystrophy in need thereof comprising administering to the human a therapeutically effective amount of a leptin protein selected from the group consisting of an amino acid sequence of SEQ ID NO: 1, wherein a methionyl residue is located at position −1, and an amino acid sequence of SEQ ID NO:2, wherein a methionyl residue is located at position −1 thereby treating said metabolic disorder. 
     
     
         34 . The method of claim  44 , wherein the human has a leptin level of 4 ng/ml or less before administration of the leptin protein. 
     
     
         35 . The method of claim  45 , wherein the human has a leptin level of 2 ng/ml or less before administration of the leptin protein. 
     
     
         36 . The method of claim  46 , wherein the human has a leptin level of 0.5 ng/ml or less before administration of the leptin protein. 
     
     
         37 . The method of claim  44 , wherein the metabolic disorder is dyslipidemia, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, atherosclerosis, vascular restenosis, fatty liver, steatohepatitis, hepatomegaly, diabetes, or insulin resistance. 
     
     
         38 . The method of claim  44 , wherein the metabolic disorder is hypertriglyceridemia or diabetes. 
     
     
         39 . The method of claim  44 , wherein the lipodystrophy is an inherited form of lipodystrophy or an acquired form of lipodystrophy. 
     
     
         40 . The method of claim  44 , wherein the lipodystrophy is generalized lipodystrophy and the metabolic disorder is hyperglycemia.