[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588499":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":29,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":29,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":29,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":29,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Adelaide","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Ca-1000","ACTIVE_COMPARATOR","In this arm, participants will receive a 75-minute intraduodenal infusion of an isotonic solution containing 3.68 g of calcium chloride dihydrate (CaCl₂·2H₂O), dissolved in 225 mL of distilled water.",[13],"Other: Ca-1000",{"label":15,"type":10,"description":16,"interventionNames":17},"Ca-500","In this arm, participants will receive a 75-minute intraduodenal infusion of an isotonic solution containing 1.84 g of calcium chloride dihydrate (CaCl₂·2H₂O), dissolved in 225 mL of distilled water. Additionally, 1.2 g of sodium chloride (NaCl) will be added to ensure the solution is isosmotic (300 mOsm).",[18],"Other: Ca-500",{"label":20,"type":21,"description":22,"interventionNames":23},"Control","PLACEBO_COMPARATOR","In this arm, participants will receive a 75-minute intraduodenal infusion of saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).",[24],"Other: Control",[26,30,33],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Calcium, an essential mineral and a key component of dairy, is a regular part of our daily diet. Recent studies have shown that calcium, at doses of 1000 mg, stimulates gut hormones and motility, will be 'higher dose' in this condition.",[9],null,{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Calcium, an essential mineral and a key component of dairy, is a regular part of our daily diet. Recent studies have shown that calcium, at doses of 500 mg, stimulates gut function. In this condition, it will be considered 'lower dose.'",[15],{"type":6,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).",[20],[37],{"name":38,"affiliation":39,"role":40},"Prof Christine Feinle-Bisset","Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},"CONTACT","+61 8 8313 6053","christine.feinle@adelaide.edu.au",{"name":47,"role":43,"phone":48,"phoneExt":29,"email":49},"Penelope Fitzgerald, MsC","+61883136278","penelope.fitzgerald@adelaide.edu.au",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Clinical Research Facility, Adelaide Health and Medical Sciences Building","RECRUITING","Adelaide","South Australia","5005","Australia","AU",{"type":60,"coordinates":61},"Point",[62,63],138.59863,-34.92866,{"lat":63,"lon":62},[66],{"name":67,"role":43,"phone":29,"phoneExt":29,"email":68},"Parisa Rouhani, MsC","parisa.rouhani@adelaide.edu.au",{"type":40,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Christine Feinle-Bisset","Professor Christine Feinle-Bisset","100588499","effects-of-calcium-on-gut-functions-and-blood-glucose-in-humans-with-type-2-diabetes-100588499",false,"NCT06942195","Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes","Effects of Intraduodenal Calcium on Plasma Glucose, Glucoregulatory Hormones and Gastric Emptying in Response to a Mixed-nutrient Drink in Humans With Type 2 Diabetes","Inclusion Criteria:\n\n* Males with type 2 diabetes mellitus (T2DM). Diagnosis of T2DM will be based on WHO criteria. Only males will be included to avoid the confounding effects of the menstrual cycle on gastric emptying.\n* BMI: 28-38 kg\u002Fm².\n* HbA1c \\>=6.5 - \\\u003C=7.9% at screening.\n* Blood glucose medications will be required to be withheld for 48 hours prior to each study day.\n* Weight-stable (i.e. \\\u003C5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 3 months.\n\nExclusion Criteria:\n\n* Significant GI symptoms, or history of GI disease or surgery\n* Current gallbladder or pancreatic disease\n* Cardiovascular or respiratory diseases\n* Any other illnesses (except type 2 diabetes) as assessed by the investigator - (including chronic illnesses not explicitly listed above)\n* Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, bodyweight or appetite (e.g. domperidone, cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)\n* Lactose intolerance\u002Fother food allergy(ies)\n* Individuals with low ferritin levels (\\\u003C30 ng\u002FmL), or who have donated blood in the 12 weeks prior to taking part in the study\n* High performance athletes\n* Current intake of \\> 2 standard drinks on \\> 5 days per week (\\>140g\u002Fweek)\n* Current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)\n* Current use of recreational drugs, e.g. marijuana\n* Current intake of any illicit substance\n* Vegetarians\n* Inability to tolerate nasoduodenal tube\n* Inability to comprehend study protocol\n* HbA1c \\\u003C6% or \\>7.9%\n* Estimated glomerular filtration rate \\\u003C45 ml\u002Fmin\n* Any patient whose medication cannot be withheld for 48 hours for medical reasons","MALE","18 Years","70 Years",{"count":83,"type":84},8,"ESTIMATED","INTERVENTIONAL",[87],"NA","The intervention in this study consists of a 75-min intraduodenal infusion of an isotonic solution containing either of calcium chloride (CaCl2) or control (saline).\n\nParticipants enrolled into the study will receive, in randomised, double-blind fashion (i) Saline (control), (ii) 500 mg CaCl2, or (iii) 1000 mg CaCl2 in three separate sessions, each of which will be separated by at least 4 (and up to 10) days. Each study session will be 4-6 hours. Studies will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide, by staff and students trained in the required techniques.",[90],"T2DM",[92,93,94,95,96,97],"Intraduodenal","Calcium","Gastric emptying","Glucoregulatory hormones","Plasma glucose","Human","2025-12-18",{"date":100,"type":101},"2025-12-26","ACTUAL",{"date":103,"type":101},"2025-05-22",{"date":105,"type":84},"2026-04-28",{"name":5,"class":6},1]