Method for diagnosing sleep apnea by measuring adipsin and betatrophin levels

Abstract

The method for diagnosing sleep apnea includes measuring concentrations of biomarkers in a patient's bodily sample. To determine whether a patient suffers from sleep apnea, or has a predisposition for developing sleep apnea, a sample from the patient is analyzed. If one or more of the following biomarker concentrations are found in the patient's sample, then the patient may be diagnosed as suffering from sleep apnea or having a predisposition for developing sleep apnea: between approximately 992.8 pg/mL and approximately 1309.6 pg/mL of adipsin; between approximately 1,640 pg/mL and approximately 2,900 pg/mL of betatrophin; between approximately 8,090.82 pg/mL and approximately 11,829.07 pg/mL of brain-derived neurotrophic factor (BDNF); between approximately 11.82 pg/mL and approximately 88.26 pg/mL of interleukin-13 (IL-13); between approximately 49.45 pg/mL and approximately 103.29 pg/mL of tumor necrosis factor- (TNF-); and between approximately 16.55 pg/mL and approximately 29.76 pg/mL of the protein encoded by Human DNAJC27.

Claims

1. A method for diagnosing sleep apnea, comprising the steps of: collecting a biological sample from a patient; analyzing the biological sample to determine a concentration of a first biomarker and a second biomarker; and diagnosing the patient as having sleep apnea if a reduced level of the first biomarker is detected in the blood sample and/or an elevated level of the second biomarker is detected in the blood sample, wherein the first biomarker is adipsin and the second biomarker is betatrophin.

2. The method for diagnosing sleep apnea as recited in claim 1, wherein: a reduced level of adipsin includes concentrations of between approximately 992.8 pg/mL and approximately 1309.6 pg/mL; and/or an increased level of betatrophin includes concentrations of between approximately 1,640 pg/mL and approximately 2,900 pg/mL.

3. The method for diagnosing sleep apnea as recited in claim 1, wherein the step of collecting the biological sample from the patient comprises collecting a biological sample selected from the group consisting of a blood sample, a urine sample, a stool sample, a saliva sample and combinations thereof.

Description

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(1) The method for diagnosing sleep apnea is a diagnostic method based on measuring concentrations of specific biomarkers in a sample from a patient. In order to determine whether a patient suffers from sleep apnea, or has a predisposition for developing sleep apnea, a sample from the patient is collected and then analyzed. The biological sample may include at least one of a blood sample, a saliva sample, a urine sample, and a stool sample. The analysis may be performed by enzyme linked immunosorbent assay (ELISA) kits or the like. A reduced level of adipsin in the sample can be indicative of sleep apnea. An elevated level of betatrophin, brain-derived neurotrophic factor (BDNP), interleukin-13 (IL-13), and/or tumor necrosis factor- (TNF-) in the sample can be indicative of sleep apnea. For example, if one or more of the following biomarker concentrations are found in the patient's biological sample, then the patient may be diagnosed as suffering from sleep apnea or having a predisposition for developing sleep apnea: between approximately 992.8 pg/mL and approximately 1309.6 pg/mL of adipsin; between approximately 1,640 pg/mL and approximately 2,900 pg/mL of betatrophin; between approximately 8,090.82 pg/mL and approximately 11,829.07 pg/mL of brain-derived neurotrophic factor (BDNF); between approximately 11.82 pg/mL and approximately 88.26 pg/mL of interleukin-13 (IL-13); between approximately 49.45 pg/mL and approximately 103.29 pg/mL of tumor necrosis factor- (TNF-); and between approximately 16.55 pg/mL and approximately 29.76 pg/mL of the protein encoded by Human DNAJC27.

(2) The concentrations of the biomarkers in the patient's biological sample may be measured by any suitable technique, such as, for example, spectrographic analysis, chemical reagents or the like, as are well known in the field of bodily fluid analysis. Further, with regard to measuring levels of the protein encoded by Human DNAJC27, it should be understood that any suitable method for measuring concentrations of protein markers in blood plasma or serum may be used, such as conventional enzyme linked immunosorbent assay (ELISA) kits or the like.

(3) In order to determine the above concentrations, concentrations of these biomarkers were measured in patients known to be suffering from sleep apnea and compared against measured concentrations from a control group of people without sleep apnea. Table 1 below summarizes these results, showing the concentration ranges of each biomarker (measured in picograms per milliliter) for the control group, for the patients with sleep apnea measured before surgical treatment for the sleep apnea, and for the patients with sleep apnea measured after surgical treatment.

(4) TABLE-US-00001 TABLE 1 Comparison of Biomarker Concentrations in Patient Blood Samples Control Pre-Treatment Post-Treatment Concentration Concentration Concentration Biomarker (pg/mL) (pg/mL) (pg/mL) Adipsin 1,309.6-4,115.2 992.8-2,384.0 1,290.4-4,889.6 Betatrophin 680.0-1,640.0 740.0-2,900.0 580.0-2,160.0 BDNF 3,530.75-8,090.82 3,502.88-11,829.07 2,714.2-11,954.5 IL-13 3.5-11.82 2.7-88.26 3.1-26.51 TNF- 12.83-49.45 13.99-103.29 12.25-84.95 Protein 0.55-16.55 1.76-29.76 2.24-26.55 (DNAJC27)

(5) Based on the data provided in Table 1, it can be seen that concentrations of between approximately 992.8 pg/mL and approximately 1309.6 pg/mL of adipsin; between approximately 1,640 pg/mL and approximately 2,900 pg/mL of betatrophin; between approximately 8,090.82 pg/mL and approximately 11,829.07 pg/mL of brain-derived neurotrophic factor (BDNF); between approximately 11.82 pg/mL and approximately 88.26 pg/mL of interleukin-13 (IL-13); between approximately 49.45 pg/mL and approximately 103.29 pg/mL of tumor necrosis factor- (TNF-); and between approximately 16.55 pg/mL and approximately 29.76 pg/mL of the protein encoded by Human DNAJC27 lie outside of the respective ranges of these biomarkers in the control group. Thus, these ranges of concentrations provide an indication for a diagnosis of sleep apnea or for a propensity to develop sleep apnea.

(6) It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.