[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653730":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":61,"studyPopulation":61,"armGroups":72,"interventions":84,"overallOfficials":89,"centralContacts":93,"locations":99,"responsibleParty":124,"collaborators":61,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":61,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":61,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":152,"whyStopped":61,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"University of Waterloo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"Glucose AUC","Glucose AUC determined from blood samples taken during a 2h oral glucose tolerance test","Visit 3 (baseline) and Visit 11 (Day 16)",[14,17,20,23,27,30,33,36,39,42,45,48,51,54,57],{"measure":15,"description":16,"timeFrame":12},"Insulin resistance\u002Fsensitivity","at rest (HOMA-IR) and during a 2 h oral glucose tolerance test (Matsuda index)",{"measure":18,"description":19,"timeFrame":12},"Markers of insulin signaling","Western blot of the following markers: AMPKα Thr172 \\& total AMPKα; phosphorylated Akt Ser437 \\& total Akt; phosphorylated TBC1D4 Thr642 \\& total TBC1D4; phosphorylated TBC1D1 Ser237 \\& total TBC1D; total GLUT4 in human skeletal muscle in the fasted and insulin stimulated state",{"measure":21,"description":22,"timeFrame":12},"Membrane bound GLUT4","GLUT4 content at the membrane in the fasted and insulin stimulated state (determined via immunofluorescence)",{"measure":24,"description":25,"timeFrame":26},"Peripheral blood mononuclear cells","determination of immune cell response to acute exercise","Visit 2 (baseline) and Visit 10 (Day 14)",{"measure":28,"description":29,"timeFrame":26},"Plasma cytokines from isolated PBMCs","pro- and anti-inflammatory cytokine content will be determine using a cytokine array and commercially available kits",{"measure":31,"description":32,"timeFrame":12},"Mitochondrial content","determined using electron microscopy",{"measure":34,"description":35,"timeFrame":12},"Mitochondrial respiration","skeletal muscle mitochondrial respiration determined using high-resolution respirometry",{"measure":37,"description":38,"timeFrame":12},"intramyocellular lipid (IMCL) content","total and subcellular location-specific content and storage characteristics",{"measure":40,"description":41,"timeFrame":26},"aerobic fitness (VO2max)","VO2max determined during a graded exercise test",{"measure":43,"description":44,"timeFrame":12},"Sex hormone concentrations","Serum estradiol measured using commercially available kits",{"measure":46,"description":47,"timeFrame":12},"Serum hormone concentrations","Serum progesterone measured using commercially available kits",{"measure":43,"description":49,"timeFrame":50},"Serum testosterone measured using commercially available kits","Visit 3 (baseline) and Visit 11 (day 16)",{"measure":46,"description":52,"timeFrame":53},"Serum growth hormone measured using commercially available kits prior to a maximal graded exercise test and immediately (t=0 min), 30 and 60 min after the graded exercise test.","Visit 2 (baseline) and visit 10 (day 14)",{"measure":46,"description":55,"timeFrame":56},"Serum glucagon measured using commercially available kits prior to a maximal graded exercise test and immediately (t=0 min), 30 and 60 min after the graded exercise test.","Visit 2 (baseline) and visit 10 (Day 14)",{"measure":58,"description":59,"timeFrame":60},"Neurotransmitter concentration","Serum epinephrine concentration measured using a commercially available kit prior to a maximal graded exercise test and immediately (t=0 min), 30 and 60 min after the graded exercise test.","Visit 2 (baseline) and Visit 10 (day 14)",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":61,"primaryPurpose":65,"observationalModel":61,"timePerspective":61,"maskingInfo":66},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":67,"maskingDescription":61,"whoMasked":68},"TRIPLE",[69,70,71],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[73,79],{"label":74,"type":75,"description":76,"interventionNames":77},"Estrogen","EXPERIMENTAL","1mg\u002Fd 17-beta estradiol x 2 day and 2mg\u002Fd 17-beta estradiol for 14 days",[78],"Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION",{"label":80,"type":81,"description":82,"interventionNames":83},"Placebo","PLACEBO_COMPARATOR","400mg\u002Fd of glucose polymer x 16 days",[78],[85],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":61},"EXERCISE TRAINING WITH OR WITHOUT MEDICATION","2 weeks of high intensity interval training while either taking estrogen or placebo",[74,80],[90],{"name":91,"affiliation":5,"role":92},"Michaela Devries, PhD","PRINCIPAL_INVESTIGATOR",[94],{"name":95,"role":96,"phone":97,"phoneExt":61,"email":98},"Vito Pipitone, PhD Candidate","CONTACT","519-888-4567","vito.pipitone@uwaterloo.ca",[100],{"facility":5,"status":61,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Waterloo","Ontario","N2L 3G1","Canada","CA",{"type":107,"coordinates":108},"Point",[109,110],-80.51639,43.4668,{"lat":110,"lon":109},[113,114,116,118,120,122],{"name":95,"role":96,"phone":97,"phoneExt":61,"email":98},{"name":115,"role":92,"phone":61,"phoneExt":61,"email":61},"Michaela Devries-Aboud, PhD",{"name":95,"role":117,"phone":61,"phoneExt":61,"email":61},"SUB_INVESTIGATOR",{"name":119,"role":117,"phone":61,"phoneExt":61,"email":61},"Emma Dare, PhD",{"name":121,"role":117,"phone":61,"phoneExt":61,"email":61},"Madeline Noble, MSc",{"name":123,"role":117,"phone":61,"phoneExt":61,"email":61},"Sean Gartner, MD",{"type":92,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"Michaela Devries-Aboud","Associate Professor","100653730","does-estrogen-blunt-the-effects-of-exercise-training-on-glycemic-control-100653730",false,"NCT07791394","Does Estrogen Blunt the Effects of Exercise Training on Glycemic Control","The Impact of 17beta-estradiol Treatment on Insulin Sensitivity, Immune Function, Inflammation and Skeletal Muscle Metabolism Following Exercise Training in Sedentary, Overweight Males","Inclusion Criteria:\n\n* Biological males (with no previous hormonal supplementation).\n* Between the ages of 18-35 years old\n* Non-smokers\n* Sedentary individuals (i.e., engaging in intentional moderate-to-vigorous physical activity \\\u003C2x\u002Fweek)\n* Body mass index 27-32 kg\u002Fm2\n* Body fat % \\> 22%\n\nExclusion Criteria:\n\n1. Any state that can impact the hormonal milieu (e.g., drug\u002Fhormonal supplementation related to health).\n2. Usage of anti-inflammatory medications, \\>1 glucose lowering medications, insulin, platelet inhibitors, anti-coagulant medications or simvastatin, beta-blockers, weight loss medications (Orlistat, Saxenda, Contrave, Ozempic) or any medications known to affect protein metabolism (i.e., corticosteroids).\n3. Presence of cardiovascular, respiratory, metabolic, autoimmune or renal disease.\n4. Presence of any condition that makes the participant unable to participate in physical activity as determined using the CSEP Get Active Questionnaire.\n5. Presence of injury that restricts exercise performance.\n6. VO2max \\> 50th percentile for age.\n7. Previous (within the last 2 months) or current use of ergogenic aids (i.e. creatine).\n8. Previous or current use of weight loss medications, including liraglutide, semaglutide, orlistat, ozempic, etc.\n9. History and\u002For diagnosis of blood clots or family history of blood clot disorders.\n10. History of allergies or sensitivities to local anesthetic\n11. Ophthalmic vascular disease\n12. Classical migraines\n13. History of thromboembolic disease\n14. Consume 15 or more alcoholic drinks\u002Fweek or 3 drinks per day\n15. Bleeding disorders\n16. Severe peripheral neuropathy\n17. Muscular dystrophy\n18. Prior bariatric surgery\n19. Osteoporosis\u002Fosteopenia\n20. Orthopaedic issues\n21. Presence of GI disorders (i.e., Colitis, Crohns disease, Celiac disease)\n22. Presence of liver disease or dysfunction (i.e., diagnosed NAFLD, NASH, cirrhosis, previous liver transplant)\n23. History of cancer\n24. Type 1 or 2 diabetes\n25. Presence of renal disorders (creatinine \\> 140)\n26. Uncontrolled hypertension (\\>140\u002F90 mmHg)\n27. History of allergies or sensitivities to estradiol or to any ingredient in the formulation or component of the container\n28. History and\u002For diagnosis of blood clots or family history of blood clot disorders\n29. Have an implantable electronic device\n30. Medical psychiatric history of depression, bipolar, anxiety, suicidal ideation, etc.\n31. Inherited clotting disorders\n32. Chest pain or shortness of breath\n33. Inflammatory disorders (e.g., inflammatory bowel disorder)\n34. Significant weight loss in the 3-month period prior to the study (10% of total body weight)\n35. Any kind of major surgery recently\n36. Bleeding disorders\n37. Active or history of thromboembolic disease (including confirmed venous thromboembolism)\n38. Ophthalmic vascular disease\n39. Classical migraines",true,"MALE","18 Years","35 Years",{"count":139,"type":140},24,"ESTIMATED","INTERVENTIONAL",[143],"NA","Previous research has found that males and females respond differently to exercise training, particularly with respect to improvements in blood sugar control and immune system health. This is crucial since insulin resistance, which can lead to type 2 diabetes and other health problems, affects millions of Canadians. People with insulin resistance often have higher inflammation. Exercise is known to improve insulin resistance and reduce inflammation, but females seem to benefit less from exercise compared to men. The investigators believe this difference might be due to estrogen, a hormone that helps regulate blood sugar (in non-exercising conditions) and reduce inflammation. Females have higher estrogen levels, which might explain their ability to regulate resting blood sugar control and also immune function at rest. Our research will investigate how estrogen influences the acute and chronic effects of exercise males. The investigators will study how estrogen influence's the body's response to exercise, particularly in terms of reducing inflammation and improving blood sugar levels as well as immune function. Overweight and obese males will undergo 2 weeks of high intensity interval training while taking either an estrogen supplement or placebo. Prior to and following training males will undergo an assessment of maximal fitness (VO2max test) and an oral glucose tolerance test. Prior to and following the acute exercise test blood samples will be taken to determine the acute effects of exercise on immune cell function and inflammation. Prior to and during the oral glucose tolerance test participants will have blood samples taken to determine glucose handling and insulin sensitivity. They will also have a muscle biopsy taken prior to and 1h into the oral glucose tolerance test to determine the effects of estrogen supplementation on insulin signaling, mitochondrial content and function, fat metabolism and fat storage in skeletal muscle.",[146],"To Determine Whether Estrogen Influences the Effects of Training on Glycemic Control and Insulin Sensitivity",[148,149,150,151],"exercise training","insulin sensitivity","glycemic control","estrogen","NOT_YET_RECRUITING","2026-08-25",{"date":155,"type":156},"2026-08-27","ACTUAL",{"date":158,"type":140},"2026-08",{"date":160,"type":140},"2027-04",{"name":5,"class":6},1]