[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07300982":3,"trial-entities:NCT07300982":108,"trial-summary:NCT07300982":112},{"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":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":76,"locations":78,"central_contacts":101,"overall_officials":104,"references":106,"see_also_links":107},"NCT07300982","Pro00117291","Studies of Insulin and Glucagon Action in the Liver","NOT_YET_RECRUITING","2029-12","2026-08","2026-08-05","2026-10","Duke University","OTHER",false,"This study examines how glucagon works to regulate glucose metabolism, based on new findings that suggest glucagon signaling in the liver has more than one role, and that these multiple roles can be opposing in nature. Understanding this biology provides an opportunity to develop new generations of glucagon-based drugs that target specific pathways, making them more effective at controlling blood glucose.\n\nParticipants will complete paired, 5-hour hyperinsulinemic glucose clamp visits in which they receive either glucagon or saline infusions while blood glucose is maintained and frequent blood samples are collected. The primary focus is whether coordinated glucagon and insulin signaling enhances hepatic insulin sensitivity.","Volunteers will undergo screening for medical history, medication usage, and blood work; those who qualify will be offered participation. Study participation will last approximately 5-12 weeks depending on appointment availability and the number of infusions planned. This protocol involves two sets of paired procedures. Approximately 15 participants will complete each set of paired visits. Participants can opt to complete one set of paired visits or both sets of paired visits.\n\nSet 1: Each participant will complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of glucagon on glucose metabolism while measuring systemic glucose turnover and related blood markers. The procedures will be identical, except for the final phase of the procedure when either saline or a stepwise glucagon infusion will be administered.\n\nSet 2: Each participant will complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of insulin on glucose metabolism while measuring systemic glucose turnover and related blood markers. The procedures will be identical, except for the final phase of the procedure when either saline or a steady glucagon infusion will be administered.",[18],"Diabetes (DM)",[20,21,22,23,24],"Glucose metabolism","Hepatic insulin sensitivity","Glucagon","Insulin","hepatic glucose production","INTERVENTIONAL","BASIC_SCIENCE",[28,29],"PHASE1","PHASE2",{"count":31,"type":32},40,"ESTIMATED",[34,39],{"type":35,"name":22,"description":36,"armGroupLabels":37},"DRUG","Glucagon infusion either graded (0.2→0.4→0.6 ng\u002Fkg\u002Fmin) or continuous (0.4 ng\u002Fkg\u002Fmin) during the final 90 minutes of a hyperinsulinemic glucose clamp. The graded or continuous glucagon infusions are given as a component of 2 separate protocols. Glucagon prepared per pharmacy\u002Fbedside protocol.",[38],"Glucagon infusion during hyperinsulinemic clamp",{"type":35,"name":40,"description":41,"armGroupLabels":42},"Saline (placebo)","IV saline infusion during clamp for 90 minutes as control.",[43],"Saline infusion during hyperinsulinemic clamp",[45,49,53],{"measure":46,"description":47,"timeFrame":48},"Glucose appearance (Ra)","Glucose appearance will be determined using steady state computations, unless a stable tracer:tracee ratio is not maintained","In these experiments outcomes will be based on measurements made in the final 90 minutes of the hyperinsulinemic glucose clamp.",{"measure":50,"description":51,"timeFrame":52},"Glucose disappearance (Rd)","Glucose disappearance (Rd) will be determined using steady state computations, unless a stable tracer:tracee ratio is not maintained","In the experiments described here glucose turnover (Ra and Rd) will be determined in the final 90 minutes of the hyperinsulinemic glucose clamp.",{"measure":21,"description":54,"timeFrame":55},"Hepatic insulin sensitivity will be calculated as EGP divided by insulin concentration","Basal period (time -30-0 min), after the insulin infusion alone (60-90 min), and during the glucagon\u002Fsaline infusions (120-180 min)",[],"ALL","18 Years","45 Years",true,{"inclusion":62,"exclusion":66,"raw_text":75},[63,64,65],"Healthy adults age 18-45 years","Body Mass Index (BMI) \\\u003C 27.0 kg\u002Fm²","Fasting plasma glucose ≤ 95 mg\u002FdL or HbA1c ≤ 5.8% as measured at screening visit",[67,68,69,70,71,72,73,74],"Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders","No personal history of diabetes or pancreatitis","No personal history of cardiac, gastrointestinal, renal or liver disease","No history of diabetes among any first-degree family members","Renal insufficiency (eGFR \\\u003C 60 mL\u002Fkg\u002Fmin)","Anemia (hematocrit \\\u003C 34%) as measured at screening visit","Pregnant females","Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)","Inclusion Criteria:\n\n* Healthy adults age 18-45 years\n* Body Mass Index (BMI) \\\u003C 27.0 kg\u002Fm²\n* Fasting plasma glucose ≤ 95 mg\u002FdL or HbA1c ≤ 5.8% as measured at screening visit\n\nExclusion Criteria:\n\n* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders\n* No personal history of diabetes or pancreatitis\n* No personal history of cardiac, gastrointestinal, renal or liver disease\n* No history of diabetes among any first-degree family members\n* Renal insufficiency (eGFR \\\u003C 60 mL\u002Fkg\u002Fmin)\n* Anemia (hematocrit \\\u003C 34%) as measured at screening visit\n* Pregnant females\n* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)",[77],"ADULT",[79],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":98},"Duke Center for Living","Durham","North Carolina","27705","United States",[86,91,95],{"name":87,"role":88,"phone":89,"email":90},"Johanna Johnson, MS","CONTACT","919-660-6766","johanna.johnson@duke.edu",{"name":92,"role":88,"phone":93,"email":94},"Alyssa Sudnick, MS","919-660-6769","alyssa.sudnick@duke.edu",{"name":96,"role":97},"David D'Alessio, MD","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},35.99403,-78.89862,[102,103],{"name":87,"role":88,"phone":89,"email":90},{"name":92,"role":88,"phone":93,"email":94},[105],{"name":96,"affiliation":12,"role":97},[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Healthy",[],{"nct_id":4,"found":60,"summary":113,"prompt_version":122},{"design":114,"status":115,"heading":6,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study involving 40 participants. It uses a hyperinsulinemic glucose clamp procedure where participants receive either glucagon or saline.","completed","This study is looking at how two hormones, insulin and glucagon, work together in the liver to control blood sugar. Researchers are trying to understand new ways glucagon affects the body, which could lead to better treatments for diabetes. You might be able to join if you are a healthy adult between 18 and 45 years old, with a BMI (Body Mass Index) under 27.0 kg\u002Fm², and normal blood sugar levels. Participants will receive either glucagon (a drug) or saline (a placebo, or inactive substance) through an IV while blood sugar is carefully monitored. The main goal is to see if insulin and glucagon working together can improve how sensitive the liver is to insulin. The current status of this study is unclear, and it plans to enroll 40 people.","Outcomes will be measured during the final 90 minutes of the hyperinsulinemic glucose clamp procedure and at specific time points during the visits.",130,"You would undergo screening, and if eligible, participate in two or four 5-hour visits where you receive IV infusions and have blood samples taken. The study participation will last approximately 5-12 weeks.","Not stated in the trial record.",[22],"v2"]