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Molecular Effects of Aspirin & Metformin on Colonic Epithelium

NCT05158374 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-06

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Aspirin tablet

75mg Aspirin once per day

DRUG

Metformin

500mg Metformin once per day

DRUG

Aspirin and Metformin

75mg Aspirin and 500mg Metformin once per day

Sponsors & Collaborators

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Farhat VN Din, FRCSed · University of Edinburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2022-10-31
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158374 on ClinicalTrials.gov