Colorectal CancerNCT05158374
Molecular Effects of Aspirin & Metformin on Colonic Epithelium
A study testing Aspirin tablet, Metformin and Aspirin and Metformin in people with Colorectal Cancer and Colorectal Neoplasms, run by University of Edinburgh.
Trial summary
Bowel cancer, a significant problem in the United Kingdom (UK) with ~ 41,000 diagnoses and ~ 16,000 deaths annually, has a large preventable component (~54%). It is, in part, due to energy imbalance within bowel cells as suggested by associated risk factors: high-fat diet, obesity, physical inactivity and type 2… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- What is being tested?
- Aspirin tablet, Metformin and Aspirin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jun 2023
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All participants who are capable of giving informed consent. All participants aged 16 years or over. All participants must have no known contraindications to rectal biopsy procedures.
- All participants must be resident in the United Kingdom. All participants must have no known contraindications to aspirin and metformin.
Who cannot join
- Unable to give informed consent. Under the age of 16 years. Individuals who are taking anti-coagulation medication. Individuals with platelet disease or other bleeding issues. Individuals with a history of a significant rectal bleed. History of diabetes mellitus or impaired glucose tolerance. Any contraindication to either aspirin or metformin. Female subjects of child bearing age who are not taking effective contraception during the period of the trial
About this study
Bowel cancer, a significant problem in the United Kingdom (UK) with ~ 41,000 diagnoses and ~ 16,000 deaths annually, has a large preventable component (~54%). It is, in part, due to energy imbalance within bowel cells as suggested by associated risk factors: high-fat diet, obesity, physical inactivity and type 2 diabetes mellitus. Drugs that decrease bowel cancer risk, like aspirin and metformin, may prevent the disease by mimicking the molecular effects of dietary restriction and exercise.
Energy imbalance, through obesity, expands stem cells which may increase bowel cancer. We have shown that aspirin activates an energy molecule, which increases when we exercise, and blocks signalling associated with obesity in bowel cancer. Indeed aspirin in combination with metformin (commonly used in diabetes) has a greater effect on this pathway than either drug alone.
Read more
To predict which patients may benefit from aspirin and metformin, we need to discover if these drugs may mimic healthy lifestyle changes at a cellular level and which cells are being targeted.
This project investigates how aspirin and metformin influence energy molecules in bowel cells to mimic beneficial effects of exercise or dietary restriction. Participants, recruited from Western General Hospital (Edinburgh) colorectal clinics, will have bowel lining and blood samples take initially and then depending on their assigned cohort, after; 24 hours, 7 days, 28 days or a 6-week course of aspirin, metformin or both tablets. Samples will be analysed for energy genes (main outcome). Secondary outcomes will measure effects on quantitative faecal immunochemical tests (qFIT), used to detect blood in the stool, and on gut bacteria.
This critical research will inform how aspirin and metformin can be used in specific populations to decrease bowel cancer risk and to develop new drugs to target abnormal energy pathways.
Read the detailed description
Colorectal cancer (CRC) is eminently preventable, and yet it is the 2nd most common cause of cancer death in the UK. Both population growth and ageing will influence CRC incidence. There is a significant environmental aetiological component, with around 54% being preventable. Modifiable risk factors include obesity, metabolic syndrome, type 2 diabetes mellitus (T2DM), and physical inactivity.Recent data suggests that the rising CRC incidence in young populations is associated with the increase in obesity and T2DM. Hence, there is substantial rationale for developing approaches that define and modify CRC obesity-related risk. Cancer cells have long been observed to reprogramme metabolism to generate substrates for growth. There are multiple molecular mechanisms linking obesity and CRC. Obesity is the commonest cause of insulin resistance and T2DM. Obesity-mediated insulin resistance and inflammation may drive CRC. Obesity increases early CRC precursor lesions of aberrant crypt foci. Bariatric surgery reduces adenomas and decreases CRC risk biomarkers such as proliferation and inflammation markers. High-fat diet (HFD) animal models of obesity and carcinogen-induced CRC show intestinal stem cell expansion. Dietary fatty acids themselves may drive stem cell expansion. Highlighting further complexity, intestinal epithelial insulin receptor deletion attenuates the HFD-induced increase in cholesterol and stem cell messenger ribonucleic acids (mRNAs).
Calorie restriction, associated with longevity and reduced cancer incidence, may be mediated through downregulation of nutrient-sensing pathways. Agents that clearly decrease CRC incidence, such as aspirin and metformin (may act as calorie restriction mimetics by influencing nutrient-sensing. The host lab have shown that low-dose aspirin reduces CRC incidence in the Scottish population and that high-energy snacks are associated with CRC risk -strengthening the link between energy, diet and cancer. They also demonstrated that aspirin modulates key nutrient-sensing pathways; aspirin activates AMP-activated protein kinase (AMPK) and inhibits mammalian target of rapamycin (mTOR) signalling in CRC cells, mouse intestine and patients. Furthermore, there was a synergistic effect with aspirin and metformin with respect to AMPK activation and mTOR inhibition in CRC cells. The protective effect of aspirin may be greater in higher body-mass index (BMI) patients. Mendelian randomisation studies strengthen causal links between obesity, hyperlipidaemia, pro-inflammatory fatty acids and CRC risk.
This study aims to elucidate the underlying molecular mechanisms of aspirin and metformin with respect to their cancer preventing properties in the colon, thereby identifying potential critical "druggable" targets. The ultimate aim is to predict which patients may benefit from these drugs to prevent CRC.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Being tested
- Aspirin tablet, Metformin, Aspirin and Metformin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin tabletDrug
Also called acetylsalicylic acid
75mg Aspirin once per day
MetforminDrug
Also called Glucophage
500mg Metformin once per day
Aspirin and MetforminDrug
Also called acetylsalicylic acid and Glucophage
75mg Aspirin and 500mg Metformin once per day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No medication, 6 weeks |
| Aspirin 24 Hours | Active comparator | 24 Hours Aspirin Receives: Drug: Aspirin tablet |
| Aspirin 7 Days | Active comparator | 7 Days Aspirin Receives: Drug: Aspirin tablet |
| Aspirin 28 Days | Active comparator | 28 Days Aspirin Receives: Drug: Aspirin tablet |
| Aspirin 6 Weeks | Active comparator | 6 Weeks Aspirin Receives: Drug: Aspirin tablet |
| Metformin 24 Hours | Active comparator | 24 Hours Metformin Receives: Drug: Metformin |
| Metformin 7 Days | Active comparator | 7 Days Metformin Receives: Drug: Metformin |
| Metformin 28 Days | Active comparator | 28 Days Metformin Receives: Drug: Metformin |
| Metformin 6 Weeks | Active comparator | 6 Weeks Metformin Receives: Drug: Metformin |
| Aspirin & Metformin 24 Hours | Active comparator | 24 Hours Aspirin \& Metformin Receives: Drug: Aspirin and Metformin |
| Aspirin & Metformin 7 Days | Active comparator | 7 Days Aspirin \& Metformin Receives: Drug: Aspirin and Metformin |
| Aspirin & Metformin 28 Days | Active comparator | 28 Days Aspirin \& Metformin Receives: Drug: Aspirin and Metformin |
| Aspirin & Metformin 6 Weeks | Active comparator | 6 Weeks Aspirin \& Metformin Receives: Drug: Aspirin and Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 24 hours Aspirin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 7 days Aspirin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 28 days Aspirin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 6 weeks Aspirin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 24 hours Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 7 days Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 28 days Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 6 weeks Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 24 hours combined Aspirin and Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 7 days combined Aspirin and Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 28 days combined Aspirin and Metformin medication
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Effect on genetic expression
Measured: Baseline and immediately after 6 weeks combined Aspirin and Metformin medication
Secondary outcomes (24)
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 24 hours Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 7 days Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 28 days Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 6 weeks Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 24 hours Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 7 days Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 28 days Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 6 weeks Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 24 hours Aspirin and Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 7 days Aspirin and Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 28 days Aspirin and Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Effect of qFIT value
Measured: Baseline and immediately after 6 weeks Aspirin and Metformin medication
Change in the proportions of bacterium in the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 24 hours Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 7 days Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 28 days Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 6 weeks Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 24 hours Metformin medication
Change in the proportions of bacterium colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 7 days Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 28 days Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 6 weeks Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 24 hours Aspirin and Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 7 days Aspirin and Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 28 days Aspirin and Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Effect on microbiome
Measured: Baseline and immediately after 6 weeks Aspirin and Metformin medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study startAug 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: withdrawn prior to gaining approvals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farhat VN Din, FRCSed, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158374
- Sponsor's protocol ID
- AC21120
- Status last verified
- Jun 2024
- First submitted
- 17 Nov 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Effects of Aspirin & Metformin on Colonic Epithelium
- ClinicalTrials.gov ID
- NCT05158374
- Acronym / sponsor ID
- AC21120
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn prior to gaining approvals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Dec 2021 (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.
Bowel cancer, a significant problem in the United Kingdom (UK) with ~ 41,000 diagnoses and ~ 16,000 deaths annually, has a large preventable component (~54%). It is, in part, due to energy imbalance within bowel cells as suggested by associated risk factors: high-fat diet, obesity, physical inactivity and type 2 diabetes mellitus. Drugs that decrease bowel cancer risk, like aspirin and metformin, may prevent the disease by mimicking the molecular effects of dietary restriction and exercise.
Energy imbalance, through obesity, expands stem cells which may increase bowel cancer. We have shown that aspirin activates an energy molecule, which increases when we exercise, and blocks signalling associated with obesity in bowel cancer. Indeed aspirin in combination with metformin (commonly used in diabetes) has a greater effect on this pathway than either drug alone.
To predict which patients may benefit from aspirin and metformin, we need to discover if these drugs may mimic healthy lifestyle changes at a cellular level and which cells are being targeted.
This project investigates how aspirin and metformin influence energy molecules in bowel cells to mimic beneficial effects of exercise or dietary restriction. Participants, recruited from Western General Hospital (Edinburgh) colorectal clinics, will have bowel lining and blood samples take initially and then depending on their assigned cohort, after; 24 hours, 7 days, 28 days or a 6-week course of aspirin, metformin or both tablets. Samples will be analysed for energy genes (main outcome). Secondary outcomes will measure effects on quantitative faecal immunochemical tests (qFIT), used to detect blood in the stool, and on gut bacteria.
This critical research will inform how aspirin and metformin can be used in specific populations to decrease bowel cancer risk and to develop new drugs to target abnormal energy pathways.
Detailed description
Colorectal cancer (CRC) is eminently preventable, and yet it is the 2nd most common cause of cancer death in the UK. Both population growth and ageing will influence CRC incidence. There is a significant environmental aetiological component, with around 54% being preventable. Modifiable risk factors include obesity, metabolic syndrome, type 2 diabetes mellitus (T2DM), and physical inactivity.Recent data suggests that the rising CRC incidence in young populations is associated with the increase in obesity and T2DM. Hence, there is substantial rationale for developing approaches that define and modify CRC obesity-related risk. Cancer cells have long been observed to reprogramme metabolism to generate substrates for growth. There are multiple molecular mechanisms linking obesity and CRC. Obesity is the commonest cause of insulin resistance and T2DM. Obesity-mediated insulin resistance and inflammation may drive CRC. Obesity increases early CRC precursor lesions of aberrant crypt foci. Bariatric surgery reduces adenomas and decreases CRC risk biomarkers such as proliferation and inflammation markers. High-fat diet (HFD) animal models of obesity and carcinogen-induced CRC show intestinal stem cell expansion. Dietary fatty acids themselves may drive stem cell expansion. Highlighting further complexity, intestinal epithelial insulin receptor deletion attenuates the HFD-induced increase in cholesterol and stem cell messenger ribonucleic acids (mRNAs).
Calorie restriction, associated with longevity and reduced cancer incidence, may be mediated through downregulation of nutrient-sensing pathways. Agents that clearly decrease CRC incidence, such as aspirin and metformin (may act as calorie restriction mimetics by influencing nutrient-sensing. The host lab have shown that low-dose aspirin reduces CRC incidence in the Scottish population and that high-energy snacks are associated with CRC risk -strengthening the link between energy, diet and cancer. They also demonstrated that aspirin modulates key nutrient-sensing pathways; aspirin activates AMP-activated protein kinase (AMPK) and inhibits mammalian target of rapamycin (mTOR) signalling in CRC cells, mouse intestine and patients. Furthermore, there was a synergistic effect with aspirin and metformin with respect to AMPK activation and mTOR inhibition in CRC cells. The protective effect of aspirin may be greater in higher body-mass index (BMI) patients. Mendelian randomisation studies strengthen causal links between obesity, hyperlipidaemia, pro-inflammatory fatty acids and CRC risk.
This study aims to elucidate the underlying molecular mechanisms of aspirin and metformin with respect to their cancer preventing properties in the colon, thereby identifying potential critical "druggable" targets. The ultimate aim is to predict which patients may benefit from these drugs to prevent CRC.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No medication, 6 weeks |
| Aspirin 24 Hours | Active comparator | Drug: Aspirin tablet24 Hours Aspirin |
| Aspirin 7 Days | Active comparator | Drug: Aspirin tablet7 Days Aspirin |
| Aspirin 28 Days | Active comparator | Drug: Aspirin tablet28 Days Aspirin |
| Aspirin 6 Weeks | Active comparator | Drug: Aspirin tablet6 Weeks Aspirin |
| Metformin 24 Hours | Active comparator | Drug: Metformin24 Hours Metformin |
| Metformin 7 Days | Active comparator | Drug: Metformin7 Days Metformin |
| Metformin 28 Days | Active comparator | Drug: Metformin28 Days Metformin |
| Metformin 6 Weeks | Active comparator | Drug: Metformin6 Weeks Metformin |
| Aspirin & Metformin 24 Hours | Active comparator | Drug: Aspirin and Metformin24 Hours Aspirin \& Metformin |
| Aspirin & Metformin 7 Days | Active comparator | Drug: Aspirin and Metformin7 Days Aspirin \& Metformin |
| Aspirin & Metformin 28 Days | Active comparator | Drug: Aspirin and Metformin28 Days Aspirin \& Metformin |
| Aspirin & Metformin 6 Weeks | Active comparator | Drug: Aspirin and Metformin6 Weeks Aspirin \& Metformin |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All participants who are capable of giving informed consent. All participants aged 16 years or over. All participants must have no known contraindications to rectal biopsy procedures.
- All participants must be resident in the United Kingdom. All participants must have no known contraindications to aspirin and metformin.
Key exclusion criteria (1 listed)
- Unable to give informed consent. Under the age of 16 years. Individuals who are taking anti-coagulation medication. Individuals with platelet disease or other bleeding issues. Individuals with a history of a significant rectal bleed. History of diabetes mellitus or impaired glucose tolerance. Any contraindication to either aspirin or metformin. Female subjects of child bearing age who are not taking effective contraception during the period of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin tabletAlso: acetylsalicylic acid75mg Aspirin once per day | Drug | Aspirin 24 Hours, Aspirin 28 Days, Aspirin 6 Weeks, Aspirin 7 Days |
| MetforminAlso: Glucophage500mg Metformin once per day | Drug | Metformin 24 Hours, Metformin 28 Days, Metformin 6 Weeks, Metformin 7 Days |
| Aspirin and MetforminAlso: acetylsalicylic acid and Glucophage75mg Aspirin and 500mg Metformin once per day | Drug | Aspirin & Metformin 24 Hours, Aspirin & Metformin 28 Days, Aspirin & Metformin 6 Weeks, Aspirin & Metformin 7 Days |
Primary outcome
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 24 hours Aspirin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 7 days Aspirin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 28 days Aspirin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 6 weeks Aspirin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 24 hours Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 7 days Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 28 days Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 6 weeks Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 24 hours combined Aspirin and Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 7 days combined Aspirin and Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 28 days combined Aspirin and Metformin medication
Effect on genetic expression
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel
Time frame: Baseline and immediately after 6 weeks combined Aspirin and Metformin medication
Effect on genetic expression
24 secondary outcomes
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 24 hours Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 7 days Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 28 days Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 6 weeks Aspirin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 24 hours Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 7 days Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 28 days Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 6 weeks Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 24 hours Aspirin and Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 7 days Aspirin and Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 28 days Aspirin and Metformin medication
Change in value of qFIT result with aspirin, metformin or combination
Time frame: Baseline and immediately after 6 weeks Aspirin and Metformin medication
Change in the proportions of bacterium in the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 24 hours Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 7 days Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 28 days Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 6 weeks Aspirin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 24 hours Metformin medication
Change in the proportions of bacterium colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 7 days Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 28 days Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 6 weeks Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 24 hours Aspirin and Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 7 days Aspirin and Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 28 days Aspirin and Metformin medication
Change in the proportions of bacterium the colorectal microbiome after aspirin and/or metformin medication
Time frame: Baseline and immediately after 6 weeks Aspirin and Metformin medication
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Farhat VN Din, FRCSed principal investigator
University of Edinburgh
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin tablet, Metformin and Aspirin and Metformin in people with Colorectal Cancer and Colorectal Neoplasms, run by University of Edinburgh.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative genetic expression change of genes relating to energy, metabolism and stem cell signalling in the large bowel (time frame: Baseline and immediately after 24 hours Aspirin medication). The study lists 12 primary outcomes in all. 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 6 Feb 2025.