[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glycemic-variability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glycemic-variability":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100650933","comparison-of-liposomal-bupivacaine-paravertebral-nerve-block-versus-intercostal-nerve-block-on-postoperative-glycemic-variability-in-patients-undergoing-minimally-invasive-pulmonary-resection-a-randomized-controlled-non-inferiority-trial-100650933",false,"NCT07754916","Comparison of Liposomal Bupivacaine Paravertebral Nerve Block Versus Intercostal Nerve Block on Postoperative Glycemic Variability in Patients Undergoing Minimally Invasive Pulmonary Resection: A Randomized Controlled Non-Inferiority Trial","Inclusion Criteria:\n\n1. Aged 18-70 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for uniportal or multiportal video-assisted thoracoscopic (VATS) minimally invasive pulmonary resection under general anesthesia.\n2. Planned to receive liposomal bupivacaine regional block analgesia under direct thoracoscopic visualization.\n3. Body mass index (BMI) 18-30 kg\u002Fm².\n4. Willing and able to cooperate with the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1. Regularly taking beta-blockers (for ≥2 weeks) or long-term use of high-dose glucocorticoids (prednisone ≥20 mg\u002Fday for \\>2 weeks).\n2. Known history of diabetes mellitus, or regular use of glucose-lowering agents (oral agents or insulin) before surgery.\n3. Planned postoperative admission to the intensive care unit (ICU).\n4. Concurrent severe cardiac (New York Heart Association class III or higher), hepatic (e.g., cirrhosis), or renal insufficiency (glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m²), or neuropsychiatric disorders.\n5. Contraindications to regional block or to any study medication, including but not limited to infection or tumor invasion at the puncture site, coagulation disorders, or allergy to any drug used in the study.\n6. Alcohol dependence: meeting the DSM-5 criteria for severe alcohol use disorder (AUD), or clinically judged as alcohol dependence (regardless of liver function status).\n7. Pregnancy or lactation (for men and women of childbearing potential, effective contraception is required until 3 months after surgery, and donation of sperm or eggs is prohibited).\n8. Participation in another interventional drug trial.\n9. Regular use of analgesics for acute or chronic pain within 2 weeks before surgery.\n10. Concurrent severe infection.\n11. Prior ipsilateral intrathoracic surgery or severe pleural adhesions (estimated to preclude successful thoracoscopic visualization and completion of the block).\n12. Psychiatric or cognitive disorders that would impair the ability to cooperate with postoperative follow-up.\n13. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the trial (for medical or safety reasons).","ALL","18 Years","70 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"NA","In this randomized controlled non-inferiority trial, we will test whether liposomal bupivacaine intercostal nerve block is non-inferior to paravertebral nerve block for the coefficient of variation (CV) of glucose during the 0- to 48-hour postoperative period, using a non-inferiority margin of Δ = 0.025 for the absolute CV difference. We will also compare the two blocks regarding their effects on postoperative glucose, autonomic function, stress, insulin resistance, acute pain, recovery quality, procedure duration, complications, and hemodynamic stability.",[26,27],"Thoracic Surgery","Glycemic Variability","NOT_YET_RECRUITING","2026-08-09",{"date":31,"type":32},"2026-08-12","ACTUAL",{"date":34,"type":20},"2026-08-01",{"date":36,"type":20},"2027-02-28",{"name":38,"class":39},"Xiangya Hospital of Central South University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100517174","predictive-value-of-glycemic-parameters-measured-with-the-fsl-pro-iq-during-acs-100517174","NCT06014112","Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS","Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome","FREESCA","Inclusion Criteria:\n\n* Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and\u002For a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI.\n\nExclusion Criteria:\n\n* Subjects in cardiogenic or septic shock\n* Subjects with ACS initially managed in a non-investigating center\n* Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU\n* Person participating in another research study with an ongoing exclusion period\n* Subjects participating in a study that may have an impact on post ACS prognosis\n* Person deprived of his or her rights, person under guardianship or curatorship\n* Person deprived of liberty (by judicial or administrative decision)\n* Persons whose physical and\u002For psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study\n* Pregnant or breastfeeding women\n* Person who is not affiliated to a social security system or who is a beneficiary of such a system.","85 Years",{"count":51,"type":20},850,[23],"Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance.\n\nHyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes.\n\nMetabolically, several situations can be distinguished:\n\n* Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \\\u003C 6.5%).\n* Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement).\n\nTo our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM.\n\nPublished studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements.\n\nThe freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.\n\nOur hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.",[55,56,27,57],"Acute Coronary Syndrome","Continuous Glucose Measurement","Cardiovascular Event",[59,60,61,62],"acute coronary syndrome","continuous glucose measurement","glycemic variability","cardiovascular event","RECRUITING","2026-06-11",{"date":66,"type":32},"2026-06-12",{"date":68,"type":32},"2023-11-06",{"date":70,"type":20},"2028-05-06",{"name":72,"class":39},"University Hospital, Montpellier",9,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":40},"100614320","impact-of-dietary-fat-and-menstrual-cycle-phases-in-type-1-diabetes-100614320","NCT07278063","Impact of Dietary Fat and Menstrual Cycle Phases in Type 1 Diabetes","Effect of Gender and Meal Composition on the Postprandial Glycemic Response in People With Type 1 Diabetes: Impact of Fat Content and Menstrual Cycle Phases","DIABETEXX\u002F3","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of type 1 diabetes mellitus for more than 2 years, in treatment with AHCL (Advanced Hybrid Closed Loop) system treatment for at least 6 months.\n* Both sexes.\n* Metabolic control with HbA1c \\\u003C8%.\n* BMI between 18.5 and 29.99 (normal weight to overweight).\n* For women: regular menstrual cycles (21-35 days in length with variation between cycles of \\\u003C4 days) and no use of hormonal contraceptive treatment.\n\nExclusion Criteria:\n\n* Diagnosis of diabetic gastroparesis.\n* Presence of hypogonadism, anovulation, hyperandrogenism, hyperprolactinemia, pregnancy, or decompensated chronic diseases.\n* Use of oral medications that alter glucose metabolism.","45 Years",{"count":84,"type":20},50,[23],"This clinical trial aims to evaluate how variations in dietary fat content and hormonal status influence postprandial glycemic response in individuals with type 1 diabetes (T1D), with a special focus on women. The main objective is to clarify the impact of both factors individually and their interaction, which could inform more personalized strategies for insulin adjustment, optimizing glycemic control, and improving patient outcomes.\n\nThe main objective is to investigate the effects of low-fat versus high-fat meals, sex, menstrual cycle phases, and their interaction on postprandial glycemic control in adults with T1D treated with advanced hybrid closed-loop (AHCL) insulin delivery systems.\n\nSpecifically, the study will:\n\n* Compare postprandial glycemic responses after standardized low and high-fat meals in men and women with T1D.\n* Assess the differences in postprandial glycemic responses between early follicular and late luteal phases in women, using standardized meals with low and high fat content.\n* Identify sex-related differences in glycemic response after equivalent meals.\n\nThis research addresses the unmet clinical need for precise, tailored postprandial insulin dosing recommendations, especially among women whose insulin sensitivity fluctuates with menstrual phases. The results may contribute to sex-specific predictive models in AHCL systems, reducing acute complications and improving overall quality of life.\n\nThis is a randomized controlled crossover trial in which each participant serves as her\u002Fhis own control. Fifty adults will be enrolled: 25 women and 25 men. Women will undergo four mixed-meal tests in random order:\n\n* low-fat given during the early follicular phase,\n* high-fat given during the early follicular phase,\n* low-fat given during the late luteal phase,\n* high-fat given during the late luteal phase. The menstrual phase will be confirmed with home-based hormonal monitoring devices that function with urine sample and use a single-use test wand (MIRA system).\n\nMen will complete two mixed-meal tests (low-fat and high-fat), in randomized order.\n\nAll meals will be standardized for carbohydrate content and matched in other macronutrients, except for fat (with a 30-40g difference), administered after an 8-hour fast. The day of the mixed meal test, AHCL systems will be switched from automatic to manual mode just before eating to standardize the prandial insulin dose and to avoid differences in insulin infusion rates in the postprandial state due to algorithm compensations. Continuous glucose monitoring (CGM) and hourly capillary glucose testing will measure the postprandial response. Additional fasting blood samples will assess metabolic, hormonal, and lipid markers. Optional gastric emptying studies may be performed to exclude confounding gastroparesis in selected patients.\n\nParticipants will be recruited from the endocrinology outpatient unit of La Fe Polytechnic University Hospital . The projected recruitment period is from December 2025 to July 2027, with mixed-meal tests and data collection occurring between January 2026 and December 2027. Women are expected to complete the protocol in 6 weeks (4 tests), while men will require about 2 weeks (2 tests).\n\nAt baseline, participants will undergo blood tests to rule out endocrine disorders and confirm sex hormone status. Women participating in the study will use the MIRA home device to monitor their hormonal levels, allowing them to accurately determine and record the phases of their menstrual cycle as part of the study protocol. During meal tests, CGM (Freestyle Libre 3) will be used uniformly among subjects.\n\nThe study dependent variables will be the following:\n\n* Postprandial glucose area under the curve - AUC\\_PG\\_5h\n* Mean glucose level - MG\n* Continuous glucose monitoring metrics - TIR, TAR, TBR\n* Postprandial glucose standard deviation - SD\n* Postprandial glucose coefficient of variation - CV\n* Mean amplitude of glycemic excursions - MAGE\n* Mean of daily differences (MODD)\n\nIndependent variables are\n\n* Type of food: Meals with either low or high fat content.\n* Sex and Hormonal status: men; women during the early follicular phase; women during the late luteal phase.\n\nIf successful, this study will inform the development of more sophisticated, individualized insulin dosing algorithms and AHCL system improvements, especially for women with T1D. Results may lead to more effective management strategies, reduced GV, lower incidence of complications, and increased quality of life. Insights may directly support the personalization of diabetes care and improve gender equity in treatment standards.",[88,27,89,90,91,92],"Type 1 Diabetes Mellitus","Sex Characteristics","Menstrual Cycle","Dietary Fat","Postprandial Glucose",[94,61,95,96,97,98,99,100,101,102],"Type 1 diabetes","advanced hybrid closed-loop systems","menstrual cycle","postprandial glucose","dietary fat","insulin sensitivity","continuous glucose monitoring","mixed-meal test","personalized insulin therapy","2026-03-20",{"date":105,"type":32},"2026-03-23",{"date":107,"type":20},"2026-05",{"date":109,"type":20},"2028-04",{"name":111,"class":39},"Instituto de Investigacion Sanitaria La Fe"]