[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04934228":3,"trial-entities:NCT04934228":129,"trial-summary:NCT04934228":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":25,"primary_purpose":13,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":50,"secondary_outcomes":71,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":14,"eligibility_criteria":75,"std_ages":98,"locations":101,"central_contacts":116,"overall_officials":123,"references":127,"see_also_links":128},"NCT04934228","00147099","Mitigating the Pro-inflammatory Phenotype of Obesity","RECRUITING","2027-08-01","2025-06","2025-06-05","2021-07-01","University of Kansas Medical Center","OTHER",false,"The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6).\n\nOur study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.","1. Using a randomized, double-blinded, parallel-design approach, we hypothesize that 4 weeks of SNA blockade (oral clonidine) will cause a significant reduction in expression of inflammatory markers in blood, endothelial cells, and central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment.\n2. Determine the extent to which inflammation in the body is caused by elevated sympathetic nerve activity",[18,19,20,21,22,23],"Blood Pressure","Diabetes","Obesity","Insulin Resistance","Diuretics Drug Reactions","Sympathetic Nerve Activity",[],"INTERVENTIONAL",[27],"PHASE1",{"count":29,"type":30},60,"ESTIMATED",[32,40,46],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Hydrochlorothiazide 12.5Mg Tab","Will receive 4 week supply (35 days) of Hydrochlorothiazide Pills (12.5 mg twice a day)\n\nPlanned use in this study\n\n1. Condition\u002Fdisease indication(s): Hypertension\n2. Subject population: Hypertension\n3. Dose(s): 25 mg\u002Fday\n4. Administration: Oral\n5. Dosing regimen: 12.5 mg twice per day",[37],"Hydrochlorothiazide (HCTZ)",[39],"Hydrochlorothiazide",{"type":33,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Clonidine Pill","Will receive 4 week supply (35 days) of Clonidine Pills (0.1 mg twice\u002Fday)\n\nPlanned use in this study\n\n1. Condition\u002Fdisease indication(s): Vascular function and blood flow\n2. Subject population: Hypertension\n3. Dose(s): 0.1 mg (oral)\n4. Administration: Oral\n5. Dosing regimen: 0.1 mg twice daily by mouth",[44],"Clonidine",[44],{"type":33,"name":47,"description":48,"armGroupLabels":49},"Placebo","Will receive a 4 week supply (35 days) of Placebo Pills; has no active ingredients but is made to look like the study drug.",[47],[51,55,58,61,64,66,69,70],{"measure":52,"description":53,"timeFrame":54},"Blood Work: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment","Difference in inflammatory markers in blood compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment\n\n* Norepinephrine (inflammation) Blood Test: pg\u002FmL normal range for norepinephrine is 70 to 1700 pg\u002FmL\n* Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg\u002FmL normal values: IL-6 was 6-31 pg\u002FmL and TNF-α 5 pg\u002FmL,\n* Nitrotyrosine (Oxidative stress)","Baseline",{"measure":56,"description":57,"timeFrame":54},"Endothelial Cell Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment","Difference in endothelial cells samples compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment\n\nEndothelial cell tissue will be assessed by the KU Histology Core for markers of inflammation and oxidative stress independently from the PI's lab,",{"measure":59,"description":60,"timeFrame":54},"Adipose Tissue Sample: Efficacy of 4-week supply of Clonidine Compared VS 4-week supply of control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment","Difference in central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment\n\nAdipose tissue are expected following 4 weeks of clonidine but not HCTZ or placebo",{"measure":52,"description":62,"timeFrame":63},"The difference in electrolytes blood test of participants in the Clonidine group compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment.\n\n• Blood Test: Electrolyte check by examining potassium concentration in blood. If potassium is 3.5 millimoles per liter or lower, oral 10 mg KCL will be prescribed to subject by a physician.","1 Week",{"measure":52,"description":62,"timeFrame":65},"2 Week",{"measure":52,"description":67,"timeFrame":68},"Difference in inflammatory markers in blood, endothelial cells, and central adipose compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment\n\n* Norepinephrine (inflammation) Blood Test: pg\u002FmL normal range for norepinephrine is 70 to 1700 pg\u002FmL\n* Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg\u002FmL normal values: IL-6 was 6-31 pg\u002FmL and TNF-α 5 pg\u002FmL,\n* Nitrotyrosine (Oxidative stress)","4 Week",{"measure":56,"description":57,"timeFrame":68},{"measure":59,"description":60,"timeFrame":68},[],"ALL","18 Years","79 Years",{"inclusion":76,"exclusion":88,"raw_text":97},[77,78,79,80,81,82,83,84,85,86,87],"Male or Female, age 18-79","Obese: BMI \\> 30 m\u002Fkg2","Hypertensive: blood pressure \\>130\u002F80","Elevated insulin resistance (HOMA-IR \\> 2.5)","Waist circ: \\>102 cm (men) and \\>88 cm (women)","Fasting glucose \\\u003C 126 mg\u002FdL","Fasting triglycerides \\\u003C 250 mg\u002FdL","HbA1c \\\u003C 6.5%","Willing to visit research lab (Fairway CTSU)","Willing to undergo a blood draw","Able to provide written informed consent",[89,90,91,92,93,94,95,96],"Current use of clonidine or beta-blockers","Current smoker or History of smoking in the past 3 months.","Hyperlipidemia: Fasting triglycerides \\> 250 mg\u002FdL","Currently taking hypertension medication","History of heart disease (e.g., myocardial infarction, stent, byass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)","History of neurological disorders","History of transplant","Actively participating in other studies, except for a registry study.","Inclusion Criteria:\n\n* Male or Female, age 18-79\n* Obese: BMI \\> 30 m\u002Fkg2\n* Hypertensive: blood pressure \\>130\u002F80\n* Elevated insulin resistance (HOMA-IR \\> 2.5)\n* Waist circ: \\>102 cm (men) and \\>88 cm (women)\n* Fasting glucose \\\u003C 126 mg\u002FdL\n* Fasting triglycerides \\\u003C 250 mg\u002FdL\n* HbA1c \\\u003C 6.5%\n* Willing to visit research lab (Fairway CTSU)\n* Willing to undergo a blood draw\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Current use of clonidine or beta-blockers\n* Current smoker or History of smoking in the past 3 months.\n* Hyperlipidemia: Fasting triglycerides \\> 250 mg\u002FdL\n* Currently taking hypertension medication\n* History of heart disease (e.g., myocardial infarction, stent, byass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)\n* History of neurological disorders\n* History of transplant\n* Actively participating in other studies, except for a registry study.",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":12,"status":7,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":113},"Kansas City","Kansas","66103","United States",[108],{"name":109,"role":110,"phone":111,"email":112},"Seth W. W Holwerda","CONTACT","9729223230","sholwerda@kumc.edu",{"lat":114,"lon":115},39.11417,-94.62746,[117,119],{"name":118,"role":110,"phone":111,"email":112},"Seth W Holwerda, Ph,D",{"name":120,"role":110,"phone":121,"email":122},"Davina A Clonch","9132266009","dclonch@kumc.edu",[124],{"name":125,"affiliation":12,"role":126},"Seth W. W Holwerda, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":130,"biomarkers":132},[131,21,20],"Hypertension",[],{"nct_id":4,"found":134,"summary":135,"prompt_version":145},true,{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is a randomized, double-blinded study with 60 planned participants. This means participants are randomly assigned to receive one of the treatments, and neither you nor the study team will know which treatment you are receiving.","completed","Study of Clonidine and Hydrochlorothiazide for Obesity and Hypertension","This study is looking at how two medications, Clonidine and Hydrochlorothiazide, affect inflammation in people who are obese and have high blood pressure. Researchers want to see if Clonidine, which helps calm down nerve activity, can reduce inflammation markers in your blood, blood vessel cells, and fat tissue. You might receive Clonidine, Hydrochlorothiazide (a diuretic, or 'water pill'), or a placebo (a pill with no active medicine). To join, you need to be 18-79 years old, obese (BMI over 30), have high blood pressure, and show signs of insulin resistance. The study aims to find out if Clonidine is better at reducing inflammation compared to Hydrochlorothiazide or a placebo. The current status of this study is unclear.","Not specified.",117,"You would receive a 4-week supply (35 days) of either Hydrochlorothiazide, Clonidine, or a placebo. Blood work, endothelial cell samples (from blood vessels), and adipose tissue samples (fat tissue) will be taken at baseline.","Not stated in the trial record.",[47],"v2"]