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DD Obesity MRI Study (DDOMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278770
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief 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. These data will be correlated with measurements of adipokines to determine if visceral fat has a specific influence on the severity of diverticular disease.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: MRI Study of Diverticular Disease Symptoms and Its Relationship to Visceral Adipose Tissue
Study Start Date : December 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Difference in the volume of visceral fat compared to abdominal subcutaneous fat between symptomatic and asymptomatic DD groups [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Serum and stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will include:

  1. Participants with symptomatic DD stratified by patient heath questionnaire 12 somatic symptom scale
  2. Participants with asymptomatic DD
Criteria

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.

    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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278770


Sponsors and Collaborators
University of Nottingham
Investigators
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Study Chair: Robin C Spiller, MD, FRCP Nottingham University Hospitals
Principal Investigator: Jan K Smith Nottingham University Hospitals
Principal Investigator: David J Humes Nottingham Unversity Hospitals
Principal Investigator: Luca Marciani Nottingham University Hospitals

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02278770    
Other Study ID Numbers: 10/H0405/80
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by University of Nottingham:
diverticular disease
MRI
visceral and subcutaneous fat
adipokines
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical