Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT04649567
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2020-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'changes in GLP-1 (iAUC) to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in bacterial composition in fecal samples', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in appetite during an ad libitum meal test by VAS scale (1-10). 10 represents highest value.', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in body weight', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in body composition (fat, bone and lean tissue) by DXA scan', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of leucocytes', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of neutrophils', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of hs-CRP', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of IL-6', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of soluble IL-6 receptor', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of IL-1Ra', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of INF-γ', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of TNF-α', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of leptin', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of adiponectin', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of IL-10', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in plasma concentration of IL-8', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in fasting plasma bile acids concentrations', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in gastric emptying rate by plasma paracetamol concentrations during a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in systemic lipid concentration by fasting plasma triglycerides, HDL and LDL cholesterol', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in unbiased mass-spectrometry (plasma proteomics that captures over 400 circulating proteins in blood including markers of low-grade inflammation and lipid metabolism)', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in the metabolome (concentrations of aminoacids) in plasma samples', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in the metabolome (concentrations of bile acids) in plasma samples', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in the metabolome (concentrations lipids) in plasma samples', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in gene Risk Score for T2D by analysing buffy coat suspension', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in quality of life measured by the questionnaire Functional Assessment of Cancer Therapy (FACT-C)', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in insulin secretion rate (ISR) by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in insulinogenic index (IGI) by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in β-cell glucose sensitivity (β-GS) by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in insulin resistance by HOMA analysis (HOMA-IR) by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in disposition index by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in insulin clearance by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in rates of absorption of the ingested glucose by an OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Change in physical activity level measured by International Physical Activity Questionnaires (IPAQ) questionnaire', 'timeFrame': '1 year after anticancer treatment'}, {'measure': 'Changes in PYY (iAUC) response to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in GLP-2 (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in GIP (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in ghrelin (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in CCK (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'changes in OXM (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in neurotensin (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in glicentin (iAUC) in responses to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in gene risk Score for T2D using buffy coat analysis', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}], 'primaryOutcomes': [{'measure': 'Changes in 2-hour blood glucose (OGTT) 12 months after hemicolectomy ± chemotherapy', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in blood glucose (iAUC) and (tAUC) in response to a 3-hour OGTT', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in hemoglobin a1c (HbA1c)', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}, {'measure': 'Changes in fasting blood glucose levels (mmol/L)', 'timeFrame': '3-4 weeks and 1 year after anticancer treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glucose Metabolism Disorders', 'Colon Cancer', 'Surgery', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'Colon cancer (CC) survivors have an increased risk of developing T2D. A recent study revealed that the surgical procedures per se may be causally involved. Hence, left-sided colon resections increased the risk of developing T2D. In addition, treatment with chemotherapy may play a role in the pathogenesis. Given the steadily improving survival rate after a CC diagnosis, prevention of secondary diseases such as T2D is important to improve quality of life in these patients and to reduce socioeconomic expenses. This study aims to elucidate the effect of resection of tumors located in the left part of the colon on pathophysiological intermediates, which may lead to T2D 12 months post-surgery or later. The physiological mechanism might be a changed postprandial secretion of gut hormones including glucagon-like peptide-1 (GLP-1) secreted from L-cells in the left part of the colon. The investigators will evaluate changes in primarily glucose homeostasis as well as in gastrointestinal hormones, microbiota, visceral fat accumulation and markers of low-grade inflammation etc. in CC survivors who underwent a left hemicolectomy or sigmoidectomy.\n\nMaterial and Methods: 60 patients will be included in this explorative clinical study. Patients will be divided into 4 groups depending on surgical procedure and treatment with chemotherapy. In the group of patients undergoing left hemicolectomy or sigmoidectomy ± treatment with chemotherapy 2 x 15 patients will be included, and in the group of patients scheduled to undergo right hemicolectomy ± treatment with chemotherapy another 2 x 15 patients will be included. During the 3 study visits (before surgery, 3-4 weeks post-surgery and 12 months post-surgery) the following tests will be performed: An oral glucose tolerance test, blood and fecal sampling, a DXA scan and an ad libitum meal test.\n\nImplications: With this study the investigators expect to obtain an insight in the pathogenesis behind the possible development of T2D in CC survivors who underwent a resection of the left part of the colon ± treatment with chemotherapy. This insight may also help scientists develop new ways of treating or preventing T2D in general.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients diagnosed with colon cancer will be investigated. They have to be planned for surgical resection of a segment of colon (left hemicolectomy, sigmoidectomy or right hemicolectomy) for cancer without signs of metastases (cT1-4N0-2M0), with and without planned treatment with adjuvant chemotherapy', 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria:\n\n* Adult (\\> 18 yrs.)\n* ASA score 1-3\n* Signed written informed consent\n* Hba1c \\<48 mmol/mol\n* Hemoglobin ≥ 6,5 mmol/L\n\nExclusion Criteria:\n\n* • Pregnancy\n\n * Known type 1 or 2 diabetes\n * Inflammatory bowel disease (Ulcerous colitis and Crohns' disease).\n * Prior major abdominal surgery including bariatric surgery or colorectal resections\n * Treatment with agents that may interfere with glucose homeostasis and or appetite or reduce the chance of successful follow-up examination\n * Planned stoma"}, 'identificationModule': {'nctId': 'NCT04649567', 'acronym': 'COLECDIAB', 'briefTitle': 'COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR - A Study of the Pathophysiological Effects of Colon Resection on Glucose Homeostasis', 'orgStudyIdInfo': {'id': 'H-20015184'}}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'state': 'Please Select', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Denmark', 'facility': 'Rigshopitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Maria S Svane, MD,PhD', 'role': 'CONTACT', 'phone': '27280918'}, {'role': 'CONTACT', 'email': 'Maria.Saur.Svane@regionh.dk'}], 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Louise L Lehrskov, MD, PhD', 'role': 'CONTACT', 'email': 'louise.lang.lehrskov.01@regionh.dk', 'phone': '0045 26817798'}, {'name': 'Maria S Svane, MD, PhD', 'role': 'CONTACT', 'phone': '27280918'}], 'overallOfficials': [{'name': 'Louise L Lehrskov, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshopitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Maria Saur Svane', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}