Skip to main content
OpenTrials
Completed

NCT Number: NCT02278770

DD Obesity MRI Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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.
  • 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.
  • 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

Treatment and study plan

Primary outcomes

  1. Difference in the volume of visceral fat compared to abdominal subcutaneous fat between symptomatic and asymptomatic DD groups

    Time frame: 3 years

Secondary outcomes

  1. Adiponectin and leptin serum levels between symptomatic and asymptomatic DD groups

    Time frame: 3 years

  2. The incidence of diarrhoea between participants with a BMI <25kg/m2 and those >25kg/m2

    Time frame: 3 years

  3. Adiponectin and leptin serum levels between DD groups with and without diarrhoea

    Time frame: 3 years

  4. Small and large bowel water and lumen diameter in symptomatic and asymptomatic DD groups

    Time frame: 3 years

  5. Calprotectin levels between symptomatic and asymptomatic DD groups

    Time frame: 3 years

  6. Microbiological gut profile between symptomatic asymptomatic DD groups

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

Pilot Study: MRI Study of Diverticular Disease Symptoms and Its Relationship to Visceral Adipose Tissue

Acronym: DDOMRI

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 30, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.