Use of Leptin for Treating Human Lipoatrophy and Method of 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 for treating cutaneous xanthomata associated with lipoatrophy in a human in need thereof comprising administering to the human a therapeutically effective amount of a leptin, leptin analog, or leptin derivative to treat the cutaneous xanthomata associated with lipoatrophy in the human. 
     
     
         34 . The method of  claim 33 , wherein the leptin, leptin analog, or leptin derivative comprises the amino acid sequence of SEQ ID NO:1. 
     
     
         35 . The method of  claim 33 , wherein the leptin, leptin analog, or leptin derivative comprises the amino acid sequence of SEQ ID NO:2. 
     
     
         36 . The method of  claim 33 , wherein the human has a leptin level of 4 ng/ml or less before administration of the leptin, leptin analog, or leptin derivative. 
     
     
         37 . The method of  claim 36 , wherein the human has a leptin level of 2 ng/ml or less before administration of the leptin protein, leptin analog, or leptin derivative. 
     
     
         38 . The method of  claim 37 , wherein the human has a leptin level of 0.05 ng/ml or less before administration of the leptin protein, leptin analog, or leptin derivative. 
     
     
         39 . A kit for determining the predisposition of a human patient with lipoatrophy to respond to treatment with recombinant methionyl human leptin comprising an enzyme-linked immunosorbent assay to determine if a serum concentration of leptin of the human patient is less than or equal to 4 ng/ml; wherein the serum concentration of leptin of less than or equal to 4 ng/ml indicates a predisposition of the human patient to respond to treatment with recombinant methionyl human leptin. 
     
     
         40 . The kit of  claim 39 , wherein the an enzyme-linked immunosorbent assay to determine if the serum concentration of leptin of the human patient is less than or equal to 2 ng/ml wherein the serum concentration of leptin of less than or equal to 2 ng/ml indicates a predisposition to respond to treatment with recombinant methionyl human leptin. 
     
     
         41 . The kit of  claim 40 , wherein the an enzyme-linked immunosorbent assay to determine if the serum concentration of leptin of the human patient is less than or equal to 0.5 ng/ml; wherein the serum concentration of leptin of less than or equal to 0.5 ng/ml indicates a predisposition to respond to treatment with recombinant methionyl human leptin.) 
     
     
         42 . The kit of  claim 39 , further comprising (i) a purified rat monoclonal anti-leptin antibody; (ii) an affinity-purified rabbit anti-leptin antibody; or (iii) a purified rat monoclonal anti-leptin antibody and an affinity-purified rabbit anti.-leptin antibody. 
     
     
         43 . The kit of  claim 42 , wherein the purified rat monoclonal anti-leptin antibody comprises an anti-rmetHu-leptin antibody, and wherein the purified rabbit polyclonal anti-leptin antibody comprises an anti-rmetHu-leptin antibody. 
     
     
         44 . A method of treating or one or more metabolic abnormalities associated with lipoatrophy in a human in need thereof comprising administering to the human a therapeutically effective amount of a leptin, leptin analog, or leptin derivative to treat the one or more metabolic abnormalities associated with lipoatrophy in the human, 
     
     
         45 . The method of  claim 44 , wherein the human has a leptin level of 4 ng/ml or less before administration of the leptin, leptin analog, or leptin derivative. 
     
     
         46 . The method of  claim 45 , wherein the human has a leptin level of 2 ng/ml less before administration of the leptin protein, leptin analog, or leptin derivative. 
     
     
         47 . The method of  claim 46 , wherein the human has a leptin level of 0.05 ng/ml or less before administration of the leptin protein, leptin analog, or leptin derivative. 
     
     
         48 . The method of  claim 44 , wherein the one or more metabolic abnormalities are selected from a group consisting of hyperglycemia, dyslipidemia, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, atherosclerosis, vascular restenosis, fatty v steatohepatitis, hepatomegaly, diabetes, and insulin resistance. 
     
     
         49 . The method of  claim 44 , wherein the one or more metabolic abnormalities are selected from a group consisting of hypertriglyceridemia and diabetes. 
     
     
         50 . The method of  claim 44 , wherein the lipoatrophy is an inherited form of lipoatrophy or an acquired form of lipoatrophy.