[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-2-diabetes-mellitus-t2d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-2-diabetes-mellitus-t2d":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100642130","impact-of-endoscopic-sleeve-gastroplasty-esg-in-obese-adults-with-type-2-diabetes-t2d-100642130",false,"NCT07639684","Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)","Metabolic Effects of Endoscopic Sleeve Gastroplasty in Obese Adults With Type 2 Diabetes: Evaluation of Glycemic Control, Insulin Use and Obesity Response","MEASURE","Inclusion Criteria:\n\n* Willing and able to provide written informed consent to participate in the study\n* Age ≥ 22 years\n* BMI 30 - 50 kg\u002Fm2\n* HbA1c 7.5 - 10.5%\n* Type 2 Diabetes treated with incretin-based medication (aka GLP-1RA agonist or GLP-1RA\u002FGIP dual agonist) at a stable, maximal tolerated dose for a minimum of 6 months +\u002F- any other oral glucose lowering medications AND intention to initiate insulin therapy for glycemic management\n* Stable weight (\\\u003C 5% TBW) within the 3 months prior to screening\n* Meets the indications for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System, excluding the following but not limited to the following: large hiatal hernia, potential bleeding gastric lesions (e.g. ulcers; erosive gastritis; varices; or vascular malformation), coagulopathy and antiplatelet\u002Fanticoagulant therapy that cannot be corrected\n* Declines or is ineligible for metabolic bariatric surgery\n* Agrees to abstain from taking any weight loss treatments or supplements that are not part of the lifestyle modification program for a year following the ESG procedure\n* Willing and able to comply with the study procedure with standard of care lifestyle modification program and visit schedule.\n\nExclusion Criteria:\n\n* Diabetes management with insulin. Prior use of insulin for gestational diabetes or short-term use (up to 1 month) in conjunction with an acute condition is acceptable.\n* Noncompliance with medication regime for diabetic management\n* More than one episode of clinically significant reactive or severe hypoglycemia within the prior 1 year. Reactive hypoglycemia is defined as postprandial hypoglycemia meeting Whipple's Triad; severe hypoglycemia is defined as any hypoglycemic episode requiring assistance from another person to administer carbohydrates, glucagon, or other corrective\u002Fresuscitative action\n* History of ketoacidosis or hyperosmolar nonketotic coma within the past 1 year\n* Has a contraindication for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System, including but not limited to the following: large hiatal hernia, potential bleeding gastric lesions (e.g. ulcers; erosive gastritis, varices, or vascular malformation), coagulopathy and antiplatelet\u002Fanticoagulant therapy that cannot be correct\n* Prior gastric surgery, including but not limited to LSG or RYGP\n* Any known conditions that impact weight loss or glycemic management\n* Chronic systemic steroids or immunosuppressants taken at the time of enrollment or likely required during the study follow-up\n* CKD stage 3+, defined as eGFR \\\u003C 60 mL\u002Fmin\n* Persistent anemia, defined as hemoglobin \\\u003C 10 g\u002FdL\n* Excessive alcohol consumption, defined as meeting or exceeding sex-based heavy drinking limits\n* Use within the last three months prior to screening of over the counter or prescribed weight loss supplements \u002F medications, or intent to use any weight loss medications or supplements during the study duration.\n* The investigator's medical judgment that the subject is not a candidate for the ESG procedure due to findings, including but not limited to psychological and nutritional evaluation results obtained in the prior 12 months.\n* Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding for a year following the ESG procedure.\n* Vulnerable subject.\n* Current or planned participation in another clinical study.","ALL","22 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.",[27,28],"Type 2 Diabetes Mellitus (T2D)","Obesity (BMI>30)",[30,31],"Endoscopic Sleeve Gastroplasty (ESG)","OverStitch","NOT_YET_RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":21},"2027-04",{"date":40,"type":21},"2029-07",{"name":42,"class":43},"Boston Scientific Corporation","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100620724","culturally-tailored-program-for-food-insecure-adults-spice-d-100620724","NCT07361341","Culturally Tailored Program for Food-Insecure Adults: SPICE-D","Culturally Tailored Program for Food-Insecure Adults With Type 2 Diabetes: The SPICE-D Study (Support for People Through Inclusive Cultural Eating for Diabetes)","SPICE-D","Inclusion Criteria:\n\n* Adults aged ≥18 years at the time of the first clinic visit during the study period; regardless of sex, gender, race, or ethnicity\n* Active patients of the Community Care Clinic (CCC) who received at least one clinical encounter between January 1, 2024 and December 31, 2024; with at least one scheduled follow-up appointment during the prospective study period\n* Meet CCC's standard eligibility criteria: Uninsured status (no health insurance coverage); Family income ≤250% of the Federal Poverty Level; Resident of Forsyth County, North Carolina, or surrounding service area\n* Completed at least one validated food insecurity screening tool during the study period as part of routine clinical care\n* Medical record contains at least one documented measurement for any of the primary outcome variables (body mass index, blood pressure, HbA1c, or healthcare utilization metric)\n* Documented diagnosis of Type 2 diabetes (ICD-10: E11.x) OR; Pre-diabetes diagnosis (ICD-10: R73.03) with a hemoglobin A1c ≥9.5%\n* Reside within designated pickup\u002Fdelivery zones for food bundle distribution (primary zip codes: 27101, 27105, 27107, and adjacent service areas)\n* Able and willing to provide written informed consent (available in English and Spanish)\n* Able to participate in baseline and follow-up assessments either in English or Spanish (the two primary languages at CCC)\n\nExclusion Criteria:\n\n* Unable to speak proficiently in English or Spanish, as this study and the CCC staff are equipped only to provide services in English and Spanish languages.\n* Have known food allergies (documented in the electronic medical record and\u002For self-reported to CCC or study staff) that may preclude participation in the food bundle program inherent to this protocol.\n* Have incomplete records. Medical charts with missing or incomplete demographic information (age, gender) that cannot be verified through other sources\n* Patients who were pregnant at any point during the study period (due to expected physiological changes in weight, blood pressure, and glucose metabolism that would confound outcome measurements)\n* Patients with documented terminal illness or hospice care during the study period, as their health trajectory and care priorities differ fundamentally from the general population\n* Transient patients. Patients who received only one-time urgent\u002Femergent care without established continuity of care at CCC (defined as \\\u003C2 visits during study period)\n* Type 1 diabetes (ICD-10: E10.x) - requires different dietary management; End-stage renal disease requiring dialysis (special dietary restrictions); Active eating disorder diagnosis; Severe food allergies that would limit ability to safely consume food bundle contents; Recent bariatric surgery (\\\u003C12 months)\n* Documented cognitive impairment or intellectual disability that would impair ability to provide informed consent or participate meaningfully in intervention without caregiver support\n* Currently enrolled in other intensive nutrition intervention studies or food prescription programs that would confound assessment of the intervention's independent effects\n* Primary language other than English or Spanish\n* Plans to move outside of CCC's service area or discontinue care at CCC within the 6-month study period\n* Physical disabilities, literacy barriers, or other factors that would prevent completion of baseline or follow-up survey instruments, unless accommodations can be reasonably made","18 Years",{"count":54,"type":21},25,[24],"The goal of this pilot intervention study is to learn if culturally appropriate food bundles and nutrition education can help people with diabetes who struggle to afford healthy food in patients with diabetes receiving care at Community Care Clinic in Winston-Salem, NC. The main questions we hope to answer are:\n\n1. Can providing culturally appropriate foods and recipes improve how people cook and prepare meals at home?\n2. Can this approach improve people's nutrition knowledge and help them better manage their diabetes?\n3. Can this approach improve overall health outcomes for people with diabetes who face food insecurity?\n\nParticipants will:\n\n1. Complete an initial interview and survey about their food security, health challenges, and social needs\n2. Receive culturally appropriate food bundles designed for their community\n3. Receive easy-to-use educational materials including recipes and cooking guides that match their reading level\n4. Complete follow-up surveys at 3 months and 6 months to track any changes in their cooking habits, nutrition knowledge, diabetes management, and health",[27],[59,60,61,62,63],"type 2 diabetes mellitus","culture","nutrition","Spanish","food insecurity","RECRUITING","2026-05-21",{"date":67,"type":36},"2026-05-26",{"date":69,"type":36},"2026-04-01",{"date":71,"type":21},"2026-10",{"name":73,"class":74},"Wake Forest University Health Sciences","OTHER",1]