[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649412":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":100,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy control","EXPERIMENTAL","The healthy controls will undergo the same assessments as the patients with CLBP, namely the high and low glycaemic index beverages. However, the healthy controls do not show signs of chronic low back pain as defined in the protocol.",[13,14,15],"Other: Glucose beverage","Other: Isomaltulose beverage","Other: Standardized breakfast",{"label":17,"type":10,"description":18,"interventionNames":19},"Patients with CLBP","Patients with CLBP will undergo the same assessments as the healthy control group, namely the high and low glycaemic index beverages. CLBP is defined as experiencing low back pain every day for at least 3 months, or every other day for at least 6 months.",[13,14,15],[21,26,30],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Glucose beverage","This beverage is made by dissolving 75 g of glucose in 200 ml of water.",[9,17],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Isomaltulose beverage","The isomaltulose beverage consists of 75 g of isomaltulose dissolved in 200 ml of water.",[9,17],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Standardized breakfast","During week 3 of the study, all partcipants consume a standardized breakfast after an overnight fast for seven days. This breakfast consists of 55g of white bread and 50g of dark chocolate. The participants are asked not to eat or perform strenuous exercise for up to two hours after consuming the breakfast.",[9,17],[35],{"name":36,"affiliation":5,"role":37},"Jo Nijs, Professor","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Joni Michiels, PhD student","CONTACT","+32471103990","Joni.Michiels2@vub.be",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"Jinane Ben Amar, PhD student","+32487219246","Jinane.Ben.Amar@vub.be",[49],{"facility":50,"status":25,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Universitair Ziekenhuis Brussel","Jette","Brussels Capital","1090","Belgium","BE",{"type":57,"coordinates":58},"Point",[59,60],4.33419,50.87309,{"lat":60,"lon":59},[63,64,65],{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},{"name":36,"role":37,"phone":25,"phoneExt":25,"email":25},{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[69,70],{"name":50,"class":6},{"name":71,"class":6},"KU Leuven","100649412","chronic-low-back-pain-comorbidities-unravelling-impaired-glucose-metabolism-100649412",false,"NCT07734714","Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism","GLOW","Inclusion Criteria:\n\n* Between 18 and 65 years old\n* For patient group: participants must comply to the non-specific CLBP criteria which are low back pain every day for three months or pain for at least half the days in the last six months, without leg pain that exceeds 7 out of 10 on a numeric rating scale and without evidence of specific spinal pathologies.\n* For healthy volunteers: pain-free for the entire duration of the study\n\nExclusion Criteria:\n\n* Systemic diseases (e.g., hypertension, cardiovascular disease, chronic gastrointestinal disorder, skin disease, active neuropathic disorder, severe eating disorders, myocardial infarction or cerebrovascular accident in the 6 months prior to the study)\n* Current pregnancy or pregnancy in the last year\n* Start-up of new medication or (dietary) treatment in the six weeks before the study\n* Antibiotic use in the three months prior to the study\n* History of bariatric surgery\n* Use of analgesics, alcohol, immunosuppressive drugs or smoking 48 hours prior to study participation\n* Classified as diabetic according to the American Diabetes criteria: fasting blood glucose ≥ 126 mg\u002Fdl, blood HbA1c ≥ 6.5%, or 2-hour PPGR ≥ 200 mg\u002Fdl\n\nAdditionally, study participation will be postponed in case the participant donated blood \\\u003C 8 weeks before baseline and participants will be asked not to donate blood for the duration of the trial.",true,"ALL","18 Years","65 Years",{"count":84,"type":85},124,"ESTIMATED","INTERVENTIONAL",[88],"NA","Chronic low back pain (CLBP) is a global health problem. The first step for developing effective treatments is a better understanding of underlying mechanisms, including its comorbidities. Cumulative findings, including breakthrough findings from our own group, point to impaired glucose metabolism as an important CLBP comorbidity. In addition to its metabolic role, the insulin-like growth factor 1 (IGF1)\u002F growth hormone (GH) axis plays a key role in pain modulation. Therefore, the project aims to examine whether DNA methylation and functional protein levels predicts postprandial glycemic responses to standardized drinks, standardized meals, and real-life meals in patients with CLBP. This will be examined using two (i.e., 1 in CLBP and 1 in healthy controls) double-blind, randomized cross-over experiments (high versus low glycaemic index beverages). After the 14-day experimental phase, all participants will be studied for an additional week to examine whether the experimental findings have ecological validity, i.e., whether they can be confirmed in response to real-life meals in their home environment. Genome-wide changes in DNA methylation will be studied using whole genome bisulfite sequencing and targeted next-generation sequencing. The project allows identification of a biomarker for a potentially very significant CLBP comorbidity, including identifying targetable mechanisms to develop innovative, personalized treatments.",[91,92],"Chronic Low Back Pain (Non-specific, Uncomplicated)","Chronic Low Back Pain (CLBP)",[94,95,96,97,98,99],"Epigenetic","DNA methylation","Glucose metabolism","IGF1\u002FGH axis","Chronic low back pain","CLBP","NOT_YET_RECRUITING","2026-07-23",{"date":103,"type":104},"2026-07-29","ACTUAL",{"date":106,"type":85},"2026-07",{"date":108,"type":85},"2030-04",{"name":5,"class":6},1]