Glucose Metabolism DisordersCOLECDIABNCT04649567
COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR
An observational study of Glucose Metabolism Disorders and Colon Cancer, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glucose Metabolism Disorders, Colon Cancer, Surgery
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Oct 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Adult (> 18 yrs.)
- ASA score 1-3
- Signed written informed consent
- Hba1c <48 mmol/mol
- Hemoglobin ≥ 6,5 mmol/L
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country.
Maria S Svane, MD, PhD contact
Denmark2 sites, 1 recruiting
- Active, not recruiting
Rigshopitalet
Copenhagen, Please Select
- Recruiting
Hvidovre Hospital
Hvidovre
Maria S Svane, MD,PhD, 27280918
Maria.Saur.Svane@regionh.dk
About this study
Official title: COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR - A Study of the Pathophysiological Effects of Colon Resection on Glucose Homeostasis
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.
- Medical subject headings
- Glucose Metabolism Disorders, Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 2-hour blood glucose (OGTT) 12 months after hemicolectomy ± chemotherapy
Measured: 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
Measured: 3-4 weeks and 1 year after anticancer treatment
Changes in hemoglobin a1c (HbA1c)
Measured: 3-4 weeks and 1 year after anticancer treatment
Changes in fasting blood glucose levels (mmol/L)
Measured: 3-4 weeks and 1 year after anticancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start10 Oct 2020
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Maria Saur Svane, Hvidovre University Hospital
- Investigators
- Louise L Lehrskov, PhD, MD, Principal investigator, Rigshopitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649567
- Sponsor's protocol ID
- H-20015184
- Acronym
- COLECDIAB
- Status last verified
- Nov 2020
- First submitted
- 2 Sep 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLONIC RESECTION FOR CANCER AS DIABETOGENIC RISK FACTOR - A Study of the Pathophysiological Effects of Colon Resection on Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT04649567
- Acronym / sponsor ID
- COLECDIAB / H-20015184
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Adult (> 18 yrs.)
- ASA score 1-3
- Signed written informed consent
- Hba1c <48 mmol/mol
- Hemoglobin ≥ 6,5 mmol/L
Key exclusion criteria (6 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in 2-hour blood glucose (OGTT) 12 months after hemicolectomy ± chemotherapy
Time frame: 3-4 weeks and 1 year after anticancer treatment
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria S Svane, MD, PhD contact
Louise L Lehrskov, PhD, MD principal investigator
Rigshopitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism Disorders and Colon Cancer, run by Hvidovre University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise L Lehrskov, MD, PhD (0045 26817798, louise.lang.lehrskov.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 2-hour blood glucose (OGTT) 12 months after hemicolectomy ± chemotherapy (time frame: 3-4 weeks and 1 year after anticancer treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.