COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR

NCT04649567 | Unknown DMC

• 1 other identifier: H-20015184
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Glucose Metabolism Disorders; Colon Cancer; Surgery; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Changes in 2-hour blood glucose (OGTT) 12 months after hemicolectomy ± chemotherapy

  3-4 weeks and 1 year after anticancer treatment

Secondary Outcomes (3)

• Changes in blood glucose (iAUC) and (tAUC) in response to a 3-hour OGTT

  3-4 weeks and 1 year after anticancer treatment

• Changes in hemoglobin a1c (HbA1c)

  3-4 weeks and 1 year after anticancer treatment

• Changes in fasting blood glucose levels (mmol/L)

  3-4 weeks and 1 year after anticancer treatment

Other Outcomes (43)

• changes in GLP-1 (iAUC) to a 3-hour OGTT

  3-4 weeks and 1 year after anticancer treatment

• changes in bacterial composition in fecal samples

  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.

  3-4 weeks and 1 year after anticancer treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult (\> 18 yrs.)
• ASA score 1-3
• Signed written informed consent
• Hba1c \<48 mmol/mol
• Hemoglobin ≥ 6,5 mmol/L

You may not qualify if:

• Pregnancy
• Known type 1 or 2 diabetes
• Inflammatory bowel disease (Ulcerous colitis and Crohns' disease).
• Prior major abdominal surgery including bariatric surgery or colorectal resections
• Treatment with agents that may interfere with glucose homeostasis and or appetite or reduce the chance of successful follow-up examination
• Planned stoma

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Rigshopitalet

Copenhagen, Please Select, Denmark

ACTIVE NOT RECRUITING

Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Louise L Lehrskov, PhD, MD

  Rigshopitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise L Lehrskov, MD, PhD

CONTACT

0045 26817798; louise.lang.lehrskov.01@regionh.dk

Maria S Svane, MD, PhD

CONTACT

27280918

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: December 2, 2020
• Study Start: October 10, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

DK (2)