An observational study in Glucose Metabolism Disorders, Colon Cancer and Surgery, sponsored by Hvidovre University Hospital. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-12-02.
Sponsored by Hvidovre University Hospital · Observational
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.
Material 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.
Implications: 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.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's planned enrollment of 60 is below the median of 176 across 300 observational studies indexed under Metabolic Diseases.
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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
Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
Pregnancy
Changes in 2-hour blood glucose (OGTT) 12 months after hemicolectomy ± chemotherapy
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in blood glucose (iAUC) and (tAUC) in response to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in hemoglobin a1c (HbA1c)
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in fasting blood glucose levels (mmol/L)
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in GLP-1 (iAUC) to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in bacterial composition in fecal samples
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in appetite during an ad libitum meal test by VAS scale (1-10). 10 represents highest value.
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in body weight
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in body composition (fat, bone and lean tissue) by DXA scan
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of leucocytes
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of neutrophils
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of hs-CRP
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of IL-6
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of soluble IL-6 receptor
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of IL-1Ra
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of INF-γ
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of TNF-α
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of leptin
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of adiponectin
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of IL-10
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in plasma concentration of IL-8
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in fasting plasma bile acids concentrations
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in gastric emptying rate by plasma paracetamol concentrations during a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in systemic lipid concentration by fasting plasma triglycerides, HDL and LDL cholesterol
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in unbiased mass-spectrometry (plasma proteomics that captures over 400 circulating proteins in blood including markers of low-grade inflammation and lipid metabolism)
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in the metabolome (concentrations of aminoacids) in plasma samples
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in the metabolome (concentrations of bile acids) in plasma samples
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in the metabolome (concentrations lipids) in plasma samples
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in gene Risk Score for T2D by analysing buffy coat suspension
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in quality of life measured by the questionnaire Functional Assessment of Cancer Therapy (FACT-C)
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in insulin secretion rate (ISR) by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in insulinogenic index (IGI) by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in β-cell glucose sensitivity (β-GS) by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in insulin resistance by HOMA analysis (HOMA-IR) by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in disposition index by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in insulin clearance by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in rates of absorption of the ingested glucose by an OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Change in physical activity level measured by International Physical Activity Questionnaires (IPAQ) questionnaire
Time frame: 1 year after anticancer treatment
Changes in PYY (iAUC) response to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in GLP-2 (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in GIP (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in ghrelin (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in CCK (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
changes in OXM (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in neurotensin (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in glicentin (iAUC) in responses to a 3-hour OGTT
Time frame: 3-4 weeks and 1 year after anticancer treatment
Changes in gene risk Score for T2D using buffy coat analysis
Time frame: 3-4 weeks and 1 year after anticancer treatment
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Hvidovre University Hospital