Diverticular DiseaseDDOMRINCT02278770
DD Obesity MRI Study
An observational study of Diverticular Disease, run by University of Nottingham.
Trial summary
In this study, our novel MRI techniques for studying the small bowel will be applied to patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be determined using MRI measurements. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diverticular Disease
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Oct 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will include: 1. Participants with symptomatic DD stratified by patient heath questionnaire 12 somatic symptom scale 2. Participants with asymptomatic DD
Who may be able to join
- Participants must have symptomatic and asymptomatic Diverticular disease confirmed on colonoscopy, barium enema or CT scan (Symptomatic disease is defined as lower abdominal pain >1hr on 3 or more days per month for longer than 3 months.)
Who cannot join
- 1. Pregnant or lactating women. 2. Severe co-morbidity; e.g. heart failure, respiratory failure, alcoholism or drug dependence, 3. Inability to give informed consent. 4. If the participant has taken part in any other study on campus in the last 3 months they will not be able to take part in this study.
- 5. Inability to lie supine 6. Inability to stop laxatives for 24hrs and antispasmodics or ondansetron for 8 hours prior to the commencement of the MRI study.
- 7. Using long-term NSAIDs (non-steroidal anti-inflammatory agents e.g. ibuprofen), antibiotics or immunosuppressant drugs 8. Antibiotics within last 3 months 9. Other gastrointestinal inflammatory problems e.g. ulcerative colitis, Crohn's or Coeliac disease
- MRI exclusions 10. Have a metallic implant 11. Have shrapnel inside the body 12. Ever had metallic fragments in the eye 13. Claustrophobia
About this study
Official title: Pilot Study: MRI Study of Diverticular Disease Symptoms and Its Relationship to Visceral Adipose Tissue
In this study, our novel MRI techniques for studying the small bowel will be applied to patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be determined using MRI measurements. These data will be correlated with measurements of adipokines to determine if visceral fat has a specific influence on the severity of diverticular disease.
Read the detailed description
Colonic diverticulosis is the most common structural abnormality of the colon and studies suggest that its incidence and/or complications are increasing. Increasing evidence suggests a link between obesity and complications of diverticular disease. With the prevalence of obesity increasing in westernised populations, the risk of complications from diverticular disease is likely to also increase. At present however, there is little understanding of how diverticular complications are increased by obesity. A high BMI might be a surrogate marker for other lifestyle factors which predispose to diverticular complications. Visceral fat may also have an influence on related complications, due to the compounds secreted by adipocytes.
Altered bowel habit is a common complaint of diverticular patients. The cause is not well understood, is probably multi-factorial, and may include changes in the small bowel. Until recently, studies of the large and small bowel required intestinal intubation and perfusion and could not be performed on the undisturbed colon. New MRI techniques have now been developed, which allow these areas to be studied non-invasively. Abdominal fat can also be measured using MRI, and the distribution of subcutaneous and visceral fat will be compared for symptomatic and asymptomatic diverticular patients.
- Conditions
- Diverticular Disease
- Keywords
- diverticular disease, MRI, visceral and subcutaneous fat, adipokines
- Medical subject headings
- Diverticular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the volume of visceral fat compared to abdominal subcutaneous fat between symptomatic and asymptomatic DD groups
Measured: 3 years
Secondary outcomes (6)
Adiponectin and leptin serum levels between symptomatic and asymptomatic DD groups
Measured: 3 years
The incidence of diarrhoea between participants with a BMI <25kg/m2 and those >25kg/m2
Measured: 3 years
Adiponectin and leptin serum levels between DD groups with and without diarrhoea
Measured: 3 years
Small and large bowel water and lumen diameter in symptomatic and asymptomatic DD groups
Measured: 3 years
Calprotectin levels between symptomatic and asymptomatic DD groups
Measured: 3 years
Microbiological gut profile between symptomatic asymptomatic DD groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startDec 2011
- Primary completionOct 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular DiseaseStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin C Spiller, MD, FRCP, Study chair, Nottingham University Hospitals NHS TrustJan K Smith, Principal investigator, Nottingham University Hospitals NHS TrustDavid J Humes, Principal investigator, Nottingham Unversity HospitalsLuca Marciani, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278770
- Sponsor's protocol ID
- 10/H0405/80
- Acronym
- DDOMRI
- Status last verified
- May 2017
- First submitted
- 28 Oct 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: MRI Study of Diverticular Disease Symptoms and Its Relationship to Visceral Adipose Tissue
- ClinicalTrials.gov ID
- NCT02278770
- Acronym / sponsor ID
- DDOMRI / 10/H0405/80
- Conditions
- Diverticular Disease
- Keywords
- diverticular disease, MRI, visceral and subcutaneous fat, adipokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Oct 2014 (estimated)
- 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.
In this study, our novel MRI techniques for studying the small bowel will be applied to patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be determined using MRI measurements. These data will be correlated with measurements of adipokines to determine if visceral fat has a specific influence on the severity of diverticular disease.
Detailed description
Colonic diverticulosis is the most common structural abnormality of the colon and studies suggest that its incidence and/or complications are increasing. Increasing evidence suggests a link between obesity and complications of diverticular disease. With the prevalence of obesity increasing in westernised populations, the risk of complications from diverticular disease is likely to also increase. At present however, there is little understanding of how diverticular complications are increased by obesity. A high BMI might be a surrogate marker for other lifestyle factors which predispose to diverticular complications. Visceral fat may also have an influence on related complications, due to the compounds secreted by adipocytes.
Altered bowel habit is a common complaint of diverticular patients. The cause is not well understood, is probably multi-factorial, and may include changes in the small bowel. Until recently, studies of the large and small bowel required intestinal intubation and perfusion and could not be performed on the undisturbed colon. New MRI techniques have now been developed, which allow these areas to be studied non-invasively. Abdominal fat can also be measured using MRI, and the distribution of subcutaneous and visceral fat will be compared for symptomatic and asymptomatic diverticular patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include: 1. Participants with symptomatic DD stratified by patient heath questionnaire 12 somatic symptom scale 2. Participants with asymptomatic DD
Key inclusion criteria (1 listed)
- Participants must have symptomatic and asymptomatic Diverticular disease confirmed on colonoscopy, barium enema or CT scan (Symptomatic disease is defined as lower abdominal pain >1hr on 3 or more days per month for longer than 3 months.)
Key exclusion criteria (4 listed)
- 1. Pregnant or lactating women. 2. Severe co-morbidity; e.g. heart failure, respiratory failure, alcoholism or drug dependence, 3. Inability to give informed consent. 4. If the participant has taken part in any other study on campus in the last 3 months they will not be able to take part in this study.
- 5. Inability to lie supine 6. Inability to stop laxatives for 24hrs and antispasmodics or ondansetron for 8 hours prior to the commencement of the MRI study.
- 7. Using long-term NSAIDs (non-steroidal anti-inflammatory agents e.g. ibuprofen), antibiotics or immunosuppressant drugs 8. Antibiotics within last 3 months 9. Other gastrointestinal inflammatory problems e.g. ulcerative colitis, Crohn's or Coeliac disease
- MRI exclusions 10. Have a metallic implant 11. Have shrapnel inside the body 12. Ever had metallic fragments in the eye 13. Claustrophobia
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
Difference in the volume of visceral fat compared to abdominal subcutaneous fat between symptomatic and asymptomatic DD groups
Time frame: 3 years
6 secondary outcomes
Adiponectin and leptin serum levels between symptomatic and asymptomatic DD groups
Time frame: 3 years
The incidence of diarrhoea between participants with a BMI <25kg/m2 and those >25kg/m2
Time frame: 3 years
Adiponectin and leptin serum levels between DD groups with and without diarrhoea
Time frame: 3 years
Small and large bowel water and lumen diameter in symptomatic and asymptomatic DD groups
Time frame: 3 years
Calprotectin levels between symptomatic and asymptomatic DD groups
Time frame: 3 years
Microbiological gut profile between symptomatic asymptomatic DD groups
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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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.
Robin C Spiller, MD, FRCP study chair
Nottingham University Hospitals NHS Trust
Jan K Smith principal investigator
Nottingham University Hospitals NHS Trust
David J Humes principal investigator
Nottingham Unversity Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease, run by University of Nottingham.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the volume of visceral fat compared to abdominal subcutaneous fat between symptomatic and asymptomatic DD groups (time frame: 3 years). 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 3 May 2017.