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<blockquote data-quote="ianf0ster" data-source="post: 2147327" data-attributes="member: 506169"><p>I have also read the short plan document for the study on Metformin.</p><p>I don't hold that much hope out for the strength of the study since the subjects will only take Metformin ER for up to 90 days with a 30 day follow-up.</p><p>Quotes from the study plan document:</p><p></p><p>"Study Design:- </p><p></p><p>Study Type : Interventional (Clinical Trial)</p><p>Estimated Enrollment : 120 participants</p><p>Allocation: Randomized</p><p>Intervention Model: Parallel Assignment</p><p>Intervention Model Description: Subjects will act as their own controls: data will be collect on each subject at baseline, throughout exposure and following, exposure to metformin.</p><p>Masking: None (Open Label)</p><p>Primary Purpose: Basic Science</p><p>Official Title: A Pilot Study: Metformin as an Inflammatory Modulating Therapy in Older Adults Without Diabetes</p><p>Actual Study Start Date : January 22, 2019</p><p>Estimated Primary Completion Date : May 2020</p><p>Estimated Study Completion Date : September 2020 "</p><p></p><p>"Subjects will have venous samples collected to better understand the cellular response to inflammation, thrombosis, and cellular respiration at baseline, at 4 time points throughout the 90 day exposure to metformin, and 30 days following the completion of exposure to metformin. At the same time points, subjects will have stool samples collected in order to assess changes in their microbiome. Finally, subjects will undergo cognitive testing through the NIH toolbox as well as physiologic testing including (six-minute walk test, grip strength as measured by a dynamometer, and a short physical performance battery) at baseline, after 90 days of exposure, and again 30 days after the completion of exposure."</p></blockquote><p></p>
[QUOTE="ianf0ster, post: 2147327, member: 506169"] I have also read the short plan document for the study on Metformin. I don't hold that much hope out for the strength of the study since the subjects will only take Metformin ER for up to 90 days with a 30 day follow-up. Quotes from the study plan document: "Study Design:- Study Type : Interventional (Clinical Trial) Estimated Enrollment : 120 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Subjects will act as their own controls: data will be collect on each subject at baseline, throughout exposure and following, exposure to metformin. Masking: None (Open Label) Primary Purpose: Basic Science Official Title: A Pilot Study: Metformin as an Inflammatory Modulating Therapy in Older Adults Without Diabetes Actual Study Start Date : January 22, 2019 Estimated Primary Completion Date : May 2020 Estimated Study Completion Date : September 2020 " "Subjects will have venous samples collected to better understand the cellular response to inflammation, thrombosis, and cellular respiration at baseline, at 4 time points throughout the 90 day exposure to metformin, and 30 days following the completion of exposure to metformin. At the same time points, subjects will have stool samples collected in order to assess changes in their microbiome. Finally, subjects will undergo cognitive testing through the NIH toolbox as well as physiologic testing including (six-minute walk test, grip strength as measured by a dynamometer, and a short physical performance battery) at baseline, after 90 days of exposure, and again 30 days after the completion of exposure." [/QUOTE]
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