[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644231":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hospital Universitario San Ignacio","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Glucerna","ACTIVE_COMPARATOR","A calorie-restricted diet plan is prescribed (see Table 1). In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan.",[13,14],"Dietary Supplement: Glucerna","Other: Caloric restriction",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","A calorie-restricted diet plan is prescribed (see Table 1). In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan. Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.",[9],null,{"type":6,"name":27,"description":18,"armGroupLabels":28,"otherNames":25},"Caloric restriction",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Ana M Gómez-Medina, Endocrinologyst","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Ana M Gómez - Medina, Endocrinologyst","CONTACT","+57 601 5946161","2817","agomez@husi.org.co",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},"Diana C Henao-Carrillo, Endocrinologyst","dchenao@husi.org.co",[44],{"facility":5,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":25,"geoPoint":25,"contacts":50},"Bogotá","Cundinamarca","111021","Colombia","CO",[51,53],{"name":52,"role":36,"phone":37,"phoneExt":38,"email":39},"Ana M Gómez Medina, Endocrinologyst",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[57],{"name":58,"class":59},"Abbott Nutrition","INDUSTRY","100644231","influence-of-the-use-of-specific-nutritional-formulas-on-time-in-range-in-patients-with-type-2-diabetes-100644231",false,"NCT07666581","Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes","Influence of the Use of Specific Nutritional Formulas for Diabetes on Time in Range in Patients With Type 2 Diabetes Mellitus With Obesity by Freestyle Continuous Glucose Monitoring","Inclusion criteria:\n\n* Patients over 18 years of age.\n* Diagnosis of diabetes mellitus type 2.\n* HbA1c \\>7% to \\\u003C11%.\n* BMI \\>27 kg\u002Fmt2 \\\u003C35 kg\u002Fmt2\n* Current use of continuous glucose monitoring with adherence greater than 70%.\n* Access to technology to download data from CGM in a timely manner.\n* Ability to follow the study protocol and provide informed consent (Appendix 3).\n\nExclusion criteria:\n\n* Change in antidiabetic medication in the last 3 months.\n* Pregnancy or lactation or planning to become pregnant during the study period.\n* Acute decompensation of diabetes in the past 3 months.\n* Participation in another clinical trial.\n* Use of glucocorticoids or insulin in the past 3 months or planned use in the coming months.\n* Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment.\n* History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes.","ALL","18 Years",{"count":70,"type":71},198,"ESTIMATED","INTERVENTIONAL",[74],"NA","Who can participate?\n\nIndividuals may be eligible to join this study if they meet the following criteria:\n\n* Are 18 years or older.\n* Have Type 2 diabetes with an A1c level higher than 7%.\n* Have a Body Mass Index (BMI) between 27 and 35 (considered overweight or Class 1 obesity).\n* Have used a continuous glucose monitor (CGM) successfully in the past.\n\nHow the study works:\n\nIf eligible individuals decide to join and sign the consent form, a computer will randomly assign them into one of two groups:\n\nThe Formula Group: Participants will replace their usual breakfast and one snack with a specific diabetes nutritional drink (Glucerna®).\n\nThe Standard Diet Group: Participants will follow a standard low-calorie meal plan without using the nutritional drink.\n\nBoth groups will aim for a specific daily calorie goal (1,200-1,500 for women; 1,500-1,800 for men) and will receive expert nutritional counseling.\n\nMonitoring and Follow-up\n\nOver the course of 3 months, close contact will be maintained to support participants:\n\nEvery 2 weeks: A nutrition expert will call participants to check on their diet and help with their glucose monitor.\n\nEvery month: Participants will meet with the study team in person to review glucose monitor data.\n\nTests: At the start and end of the study, weight, body composition, blood sugar (A1c), and cholesterol levels will be measured to see how the plans worked.",[77,78,79],"Type 2 Diabetes","Obesity & Overweight","Time in Range",[77,81,82,79],"Obesity","Continuos Glucose Monitoring","NOT_YET_RECRUITING","2026-06-18",{"date":86,"type":87},"2026-06-24","ACTUAL",{"date":89,"type":71},"2026-08",{"date":91,"type":71},"2028-12",{"name":5,"class":6},1]