Indicators of altered mitochondrial function in predictive methods for determining risk of type 2 diabetes mellitus

Abstract

The present invention relates to improved diagnostic methods for early detection of a risk for developing type 2 diabetes mellitus in humans, and screening assays for therapeutic agents useful in the treatment of type 2 diabetes mellitus, by comparing the levels of one or more indicators of altered mitochondrial function. Indicators of altered mitochondrial function include enzymes such as mitochondrial enzymes and ATP biosynthesis factors. Other indicators of altered mitochondrial function include mitochondrial mass, mitochondrial number and mitochondrial DNA content, cellular responses to elevated intracellular calcium and to apoptogens, and free radical production. Methods of treating, and of stratifying, human patients as such methods relate to disclosed indicators of altered mitchondrial function are also provided.

What is claimed is:  
     
         1 . A method for identifying a risk for Type 2 diabetes in a human subject, comprising: 
 comparing the level of at least one indicator of altered mitochondrial function in a biological sample from the subject with a control sample; and therefrom identifying the risk for Type 2 diabetes.    
     
     
         2 . A method for determining a degree of disease progression in a human subject having Type 2 diabetes, comprising: 
 comparing the level of at least one indicator of altered mitochondrial function in each of first and second biological samples, said first and second biological samples being obtained from said subject at a first time point and a second time point, respectively; and therefrom determining the degree of progression of Type 2 diabetes.    
     
     
         3 . A method of identifying an agent suitable for treating a human subject suspected of being at risk for having type 2 diabetes, comprising: 
 comparing the level of at least one indicator of altered mitochondrial function in one or more biological samples obtained from the subject in the presence and absence of a candidate agent; and therefrom determining the suitability of said candidate agent for treating type 2 diabetes.