Table 3.
Summary of clinical trials on SIRT1 activators for fatty liver diseases and other metabolic diseases.
| Study description | Phase | Identifier | Drugs | Diseases or Conditions | Status | Study period | |||
|---|---|---|---|---|---|---|---|---|---|
| Studies on fatty liver diseases | |||||||||
| 1 | The effects of resveratrol on lipid profiles, liver enzymes, inflammatory factors and hepatic fibrosis in nonalcoholic steatohepatitis patients | II & III | NCT02030977 | Resveratrol | NAFLD | Completed | Jun. 2012-Mar. 2013 | ||
| 2 | Safety and efficacy of resveratrol for the treatment of NAFLD and associated insulin resistance in overweight and obese adolescents | II & III | NCT02216552 | Resveratrol | NAFLD; Obesity | Recruiting | Aug. 2015- | ||
| 3 | Resveratrol in patients with non-alcoholic fatty liver disease | - | NCT01464801 | Resveratrol | NAFLD | Completed | Sep.2011-Jun. 2015 | ||
| 4 | Evaluate the effects of resveratrol on liver fat content, body fat distribution and insulin sensitivity | - | NCT01635114 | Resveratrol | NAFLD; Insulin resistance | Completed | Jun. 2012-Sep. 2015 | ||
| 5 | Long-term investigation of resveratrol on lipid turnover in obese men with NAFLD | - | NCT01446276 | Resveratrol | NAFLD; Obesity | Completed | Nov.2011-Apr. 2014 | ||
| Studies on metabolic diseases (disorders) associated inflammation and/or oxidative stress | |||||||||
| 6 | Effects of resveratrol on inflammation and oxidative stress of non-dialysis chronic kidney diseases patients | III | NCT02433925 | Resveratrol | Chronic renal insufficiency | Completed | Jan. 2013-Dec. 2014 | ||
| 7 | Anti-inflammatory and antioxidant effects of resveratrol on healthy adults | III | NCT01492114 | Resveratrol | Healthy volunteer | Completed | Jul. 2011-Mar. 2012 | ||
| 8 | Effects of resveratrol on inflammation in type 2 diabetic patients | III | NCT02244879 | Resveratrol | Type 2 diabetes | Completed | Oct 2013-Feb. 2016 | ||
| 9 | Effect of resveratrol on insulin resistance and inflammatory mediators in obese and type 2 diabetic subjects | II & III | NCT01158417 | Resveratrol | Type 2 diabetes; Obesity | Unknown | Dec. 2008- | ||
| 10 | Effect of resveratrol on age-related insulin resistance and inflammation in humans | II | NCT01354977 | Resveratrol | Type 2 diabetes; Insulin resistance | Unknown | Mar. 2008- | ||
| 11 | The effects of trans-resveratrol on insulin resistance, inflammation, and the metabolic syndrome | II | NCT01714102 | Resveratrol | Obesity; Insulin resistance | Active, not recruiting | Oct. 2012- | ||
| 12 | A phase I dose-ranging study to evaluate the activity of SRT2379 on endotoxin induced inflammatory response in healthy male subjects | I | NCT01416376 | SRT2379 | Healthy volunteer treated with LPS | Completed | Aug. 2011-Dec. 2011 | ||
| 13 | A phase I study to evaluate a single oral dose of SRT2379 on the endotoxin induced inflammatory response in healthy male subjects | I | NCT01262911 | SRT2379 | Healthy volunteer treated with LPS | Completed | Feb. 2011-Apr. 2011 | ||
| 14 | A phase I study to evaluate multiple oral doses of SRT2104 on the endotoxin induced inflammatory response in healthy male subjects | I | NCT01014117 | SRT2104 | Healthy volunteer treated with LPS | Completed | Dec. 2009-May. 2010 | ||
| 15 | Long-term investigation of resveratrol on management of metabolic syndrome, osteoporosis and inflammation | - | NCT01412645 | Resveratrol | Metabolic syndrome | Completed | Aug. 2011-Aug. 2013 | ||
| 16 | The effects of resveratrol supplementation on measurements of health and human performance | - | NCT01244360 | Resveratrol | Healthy volunteer | Unknown | Nov. 2010- | ||
| 17 | Potential beneficial effects of resveratrol on obesity, metabolic syndrome and inflammation | - | NCT01150955 | Resveratrol | Metabolic syndrome; Obesity | Completed | Oct. 2010-Nov. 2011 | ||
| Studies on other metabolic diseases (disorders) at phase IV | |||||||||
| 18 | Effect of resveratrol on improving insulin sensitivity and preserving beta cell function following gestational diabetes | IV | NCT01997762 | Resveratrol | Gestational diabetes | Unknown | May 2014- | ||
| 19 | Effects of simvastatin and micronized trans-resveratrol treatment on polycystic ovary syndrome (PCOS) patients | IV | NCT02766803 | SRT501; Simvastatin | PCOS; Insulin resistance | Recruiting | May 2016- | ||
| Studies on other newly developed potent SIRT1 activators | |||||||||
| 20 | A phase II study to assess the safety, tolerability, and activity of oral SRT2104 capsules administered in type 2 diabetes subjects | II | NCT01018017 | SRT2104 | Type 2 diabetes | Completed | Mar. 2010-Dec. 2010 | ||
| 21 | A phase II study to assess the safety and pharmacokinetics of SRT2104 in type 2 diabetic human subjects | II | NCT00937326 | SRT2104 | Type 2 diabetes | Completed | Aug. 2009-Sep. 2010 | ||
| 22 | A phase I study in healthy male volunteers to investigate different doses of SRT3025 for the treatment of metabolic diseases | I | NCT01340911 | SRT3025 | Healthy volunteer | Completed | Jun. 2011-Feb. 2012 | ||
| 23 | A phase I study to assess the pharmacokinetics of SRT2104 administered as an oral suspension or capsule formulation to normal healthy volunteers | I | NCT00938275 | SRT2104 | Healthy volunteer | Completed | Jan. 2009-Mar. 2009 | ||
| 24 | A phase I study to assess the pharmacokinetics, safety and tolerability of SRT2104 administered to normal healthy male volunteers | I | NCT00933062 | SRT2104 | Healthy volunteer | Completed | Mar. 2009-May 2009 | ||
| 25 | Evaluation of the pharmacokinetics and the absolute bioavailability of SRT2104 in healthy male subjects | I | NCT00937872 | SRT2104 | Healthy volunteer | Completed | Nov. 2008-Dec. 2008 | ||
| 26 | A phase I study to assess the safety of oral SRT2104 and its effects on vascular dysfunction in healthy and type 2 diabetes subjects | I | NCT01031108 | SRT2104 | Type 2 diabetes | Completed | May 2010-Oct. 2011 | ||
| 27 | A phase I study to assess the safety and pharmacokinetics of SRT2104 in normal healthy male volunteers | I | NCT00933530 | SRT2104 | Healthy volunteer | Completed | May 2008-Nov. 2008 | ||
| 28 | A phase I study to assess the safety and pharmacokinetics of SRT2379 in normal healthy male volunteers | I | NCT01018628 | SRT2379 | Healthy volunteer | Completed | Dec. 2009-Aug. 2010 | ||