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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Calculate Free Testosterone with TruT by FPT
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<blockquote data-quote="madman" data-source="post: 144976" data-attributes="member: 13851"><p>It seems so and they are in the process of completing PHASE II.</p><p></p><p>I would like to see more members post comparisons of their FT numbers using Equilibrium Dialysis to Tru T Free Testosterone calculator.</p><p></p><p>Mind you unfortunately most are still using the direct immunoassay and tracer analog.</p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p><strong>Phase II: <span style="color: rgb(184, 49, 47)">Research and Commercialization </span>of <span style="color: rgb(184, 49, 47)">TruT Algorithm</span> for Free Testosterone</strong></p><p></p><p></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">ABSTRACT</span></strong></p><p></p><p>- the measurement of testosterone(T) levels is central to the diagnosis of androgen disorders, such as hypogonadism in men and polycystic ovary syndrome (PCOS) in women</p><p></p><p>- circulating t is bound with high affinity to sex hormone binding globulin (SHBG) and with substantially lower affinity to albumin; only the free fraction is biologically active</p><p></p><p>- conditions that affect SHBG concentrations, such as aging and obesity, alter total T but not free T concentrations; in these conditions, the determination of free t is necessary to obtain an accurate assessment of androgen status</p><p></p><p>- tracer analog method, the most widely used method for free T, has been shown to be inaccurate</p><p></p><p>- equilibrium dialysis method is, technically difficult to implement and standardize, and is not available in most hospital laboratories, leading the Endocrine Society's Expert Panel to conclude that?? the calculation of free testosterone is the most useful estimate of free testosterone in plasma??</p><p></p><p>- therefore, there is an unmet need for algorithms that provide accurate estimates of free T that match those derived from equilibrium dialysis</p><p></p><p>- we have designed a novel and accurate TruTTM algorithm for the determination of free T, based on the characterization of testosterones's binding to SHBG using modern biophysical techniques</p><p></p><p>- we have discovered that testosterone's binding to SHBG is a dynamic multistep process that includes allosteric interaction between the two binding sites on an SHBG dimer</p><p></p><p>- our computational frame-work incorporates the correct binding parameters derived experimentally in these studies, the non-linear dynamics in T:SHBG association, and allsotery</p><p></p><p><strong>- in <span style="color: rgb(184, 49, 47)">phase I studies</span> , we <span style="color: rgb(184, 49, 47)">demonstrated that TruTTM algorithm</span> provides <span style="color: rgb(184, 49, 47)">accurate free T values </span>that match those obtained using the <span style="color: rgb(184, 49, 47)">equilibrium dialysis </span>in <span style="color: rgb(184, 49, 47)">healthy and hypogonadal men</span></strong></p><p></p><p><span style="color: rgb(0, 0, 0)"><strong>- we have also shown that the </strong></span><span style="color: rgb(184, 49, 47)"><strong>binding parameters </strong></span><span style="color: rgb(0, 0, 0)"><strong>that have </strong></span><span style="color: rgb(184, 49, 47)"><strong>formed the basis of previous equations </strong></span><span style="color: rgb(0, 0, 0)"><strong>(e.g., Vermeulen)</strong></span><span style="color: rgb(184, 49, 47)"><strong> are incorrect</strong></span><span style="color: rgb(0, 0, 0)"><strong>, and that </strong></span><span style="color: rgb(184, 49, 47)"><strong>free T values</strong></span><span style="color: rgb(0, 0, 0)"><strong> derived using these equations </strong></span><span style="color: rgb(184, 49, 47)"><strong>deviate substantially</strong></span><span style="color: rgb(0, 0, 0)"><strong> from </strong></span><span style="color: rgb(184, 49, 47)"><strong>free T measured by equilibrium dialysis</strong></span></p><p></p><p><span style="color: rgb(0, 0, 0)"><strong>- the </strong></span><span style="color: rgb(184, 49, 47)"><strong>phase I studies </strong></span><span style="color: rgb(0, 0, 0)"><strong>have led to </strong></span><span style="color: rgb(184, 49, 47)"><strong>adoption</strong></span><span style="color: rgb(0, 0, 0)"><strong> of the </strong></span><span style="color: rgb(184, 49, 47)"><strong>TruTTM algorithm</strong></span><span style="color: rgb(0, 0, 0)"><strong> at </strong></span><span style="color: rgb(184, 49, 47)"><strong>several institutions</strong></span></p><p></p><p><strong>- the<span style="color: rgb(184, 49, 47)"> phase II program</span> will continue the <span style="color: rgb(184, 49, 47)">development of the TruTTM algorithm</span> by <span style="color: rgb(184, 49, 47)">validating it</span> in common conditions characterized by <span style="color: rgb(184, 49, 47)">altered SHBG concentration</span>, such as obesity and aging (AIM 1), in healthy women across the menstrual cycle, and in women with PCOS (AIM 2)</strong></p><p></p><p><strong>- we will <span style="color: rgb(184, 49, 47)">generate population-based reference ranges for free T</span> (AIM 3)</strong></p><p></p><p><strong>- <span style="color: rgb(184, 49, 47)">phase II </span>also includes <span style="color: rgb(184, 49, 47)">plans for commercialization of the TruTTM algorithm </span>using a <span style="color: rgb(184, 49, 47)">HIPAA compliant infrastructure </span>for its <span style="color: rgb(184, 49, 47)">clinical adoption</span></strong></p><p></p><p><strong>-the <span style="color: rgb(184, 49, 47)">phase II program </span>will provide <span style="color: rgb(184, 49, 47)">validation of TruTTM algorithm</span> in the <span style="color: rgb(184, 49, 47)">two most common clinical indications for free T measurement? </span>men suspected of <span style="color: rgb(184, 49, 47)">hypogonadism</span> and<span style="color: rgb(184, 49, 47)"> altered SHBG levels</span>, and women with <span style="color: rgb(184, 49, 47)">hyperandrogenic disorders</span></strong></p><p></p><p><strong><span style="color: rgb(0, 0, 0)">- it will also </span><span style="color: rgb(184, 49, 47)">enable the development of a HIPAA compliant platform </span><span style="color: rgb(0, 0, 0)">that can be </span><span style="color: rgb(184, 49, 47)">embedded into electronic medical record</span><span style="color: rgb(0, 0, 0)"> for </span><span style="color: rgb(184, 49, 47)">wider clinical adoption</span><span style="color: rgb(0, 0, 0)"> and for </span><span style="color: rgb(184, 49, 47)">improving clinical care</span></strong></p><p></p><p></p><p></p><p>Project Start 2014-09-15</p><p><strong>Project End <span style="color: rgb(184, 49, 47)">2019-05-31</span></strong></p><p></p><p></p><p></p><p><a href="http://grantome.com/grant/NIH/R44-AG045011-02" target="_blank">Phase II: Research and Commercialization of TruT Algorithm for Free Testosterone</a></p></blockquote><p></p>
[QUOTE="madman, post: 144976, member: 13851"] It seems so and they are in the process of completing PHASE II. I would like to see more members post comparisons of their FT numbers using Equilibrium Dialysis to Tru T Free Testosterone calculator. Mind you unfortunately most are still using the direct immunoassay and tracer analog. [B]Phase II: [COLOR=rgb(184, 49, 47)]Research and Commercialization [/COLOR]of [COLOR=rgb(184, 49, 47)]TruT Algorithm[/COLOR] for Free Testosterone[/B] [B][COLOR=rgb(184, 49, 47)]ABSTRACT[/COLOR][/B] - the measurement of testosterone(T) levels is central to the diagnosis of androgen disorders, such as hypogonadism in men and polycystic ovary syndrome (PCOS) in women - circulating t is bound with high affinity to sex hormone binding globulin (SHBG) and with substantially lower affinity to albumin; only the free fraction is biologically active - conditions that affect SHBG concentrations, such as aging and obesity, alter total T but not free T concentrations; in these conditions, the determination of free t is necessary to obtain an accurate assessment of androgen status - tracer analog method, the most widely used method for free T, has been shown to be inaccurate - equilibrium dialysis method is, technically difficult to implement and standardize, and is not available in most hospital laboratories, leading the Endocrine Society's Expert Panel to conclude that?? the calculation of free testosterone is the most useful estimate of free testosterone in plasma?? - therefore, there is an unmet need for algorithms that provide accurate estimates of free T that match those derived from equilibrium dialysis - we have designed a novel and accurate TruTTM algorithm for the determination of free T, based on the characterization of testosterones's binding to SHBG using modern biophysical techniques - we have discovered that testosterone's binding to SHBG is a dynamic multistep process that includes allosteric interaction between the two binding sites on an SHBG dimer - our computational frame-work incorporates the correct binding parameters derived experimentally in these studies, the non-linear dynamics in T:SHBG association, and allsotery [B]- in [COLOR=rgb(184, 49, 47)]phase I studies[/COLOR] , we [COLOR=rgb(184, 49, 47)]demonstrated that TruTTM algorithm[/COLOR] provides [COLOR=rgb(184, 49, 47)]accurate free T values [/COLOR]that match those obtained using the [COLOR=rgb(184, 49, 47)]equilibrium dialysis [/COLOR]in [COLOR=rgb(184, 49, 47)]healthy and hypogonadal men[/COLOR][/B] [COLOR=rgb(0, 0, 0)][B]- we have also shown that the [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]binding parameters [/B][/COLOR][COLOR=rgb(0, 0, 0)][B]that have [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]formed the basis of previous equations [/B][/COLOR][COLOR=rgb(0, 0, 0)][B](e.g., Vermeulen)[/B][/COLOR][COLOR=rgb(184, 49, 47)][B] are incorrect[/B][/COLOR][COLOR=rgb(0, 0, 0)][B], and that [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]free T values[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] derived using these equations [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]deviate substantially[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] from [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]free T measured by equilibrium dialysis[/B][/COLOR] [COLOR=rgb(0, 0, 0)][B]- the [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]phase I studies [/B][/COLOR][COLOR=rgb(0, 0, 0)][B]have led to [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]adoption[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] of the [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]TruTTM algorithm[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] at [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]several institutions[/B][/COLOR] [B]- the[COLOR=rgb(184, 49, 47)] phase II program[/COLOR] will continue the [COLOR=rgb(184, 49, 47)]development of the TruTTM algorithm[/COLOR] by [COLOR=rgb(184, 49, 47)]validating it[/COLOR] in common conditions characterized by [COLOR=rgb(184, 49, 47)]altered SHBG concentration[/COLOR], such as obesity and aging (AIM 1), in healthy women across the menstrual cycle, and in women with PCOS (AIM 2)[/B] [B]- we will [COLOR=rgb(184, 49, 47)]generate population-based reference ranges for free T[/COLOR] (AIM 3)[/B] [B]- [COLOR=rgb(184, 49, 47)]phase II [/COLOR]also includes [COLOR=rgb(184, 49, 47)]plans for commercialization of the TruTTM algorithm [/COLOR]using a [COLOR=rgb(184, 49, 47)]HIPAA compliant infrastructure [/COLOR]for its [COLOR=rgb(184, 49, 47)]clinical adoption[/COLOR][/B] [B]-the [COLOR=rgb(184, 49, 47)]phase II program [/COLOR]will provide [COLOR=rgb(184, 49, 47)]validation of TruTTM algorithm[/COLOR] in the [COLOR=rgb(184, 49, 47)]two most common clinical indications for free T measurement? [/COLOR]men suspected of [COLOR=rgb(184, 49, 47)]hypogonadism[/COLOR] and[COLOR=rgb(184, 49, 47)] altered SHBG levels[/COLOR], and women with [COLOR=rgb(184, 49, 47)]hyperandrogenic disorders[/COLOR][/B] [B][COLOR=rgb(0, 0, 0)]- it will also [/COLOR][COLOR=rgb(184, 49, 47)]enable the development of a HIPAA compliant platform [/COLOR][COLOR=rgb(0, 0, 0)]that can be [/COLOR][COLOR=rgb(184, 49, 47)]embedded into electronic medical record[/COLOR][COLOR=rgb(0, 0, 0)] for [/COLOR][COLOR=rgb(184, 49, 47)]wider clinical adoption[/COLOR][COLOR=rgb(0, 0, 0)] and for [/COLOR][COLOR=rgb(184, 49, 47)]improving clinical care[/COLOR][/B] Project Start 2014-09-15 [B]Project End [COLOR=rgb(184, 49, 47)]2019-05-31[/COLOR][/B] [URL='http://grantome.com/grant/NIH/R44-AG045011-02']Phase II: Research and Commercialization of TruT Algorithm for Free Testosterone[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Blood Test Discussion
Calculate Free Testosterone with TruT by FPT
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