DD Obesity MRI Study

NCT02278770 | Completed

• 1 other identifier: 10/H0405/80
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diverticular Disease

Keywords

diverticular disease; MRI; visceral and subcutaneous fat; adipokines

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (6)

• Adiponectin and leptin serum levels between symptomatic and asymptomatic DD groups

  3 years

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

  3 years

• Adiponectin and leptin serum levels between DD groups with and without diarrhoea

  3 years

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

  3 years

• Calprotectin levels between symptomatic and asymptomatic DD groups

  3 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.)

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of Nottingham: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum and stool

MeSH Terms

Conditions

Diverticular Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robin C Spiller, MD, FRCP

  Nottingham University Hospitals

  STUDY CHAIR

• Jan K Smith

  Nottingham University Hospitals

  PRINCIPAL INVESTIGATOR

• David J Humes

  Nottingham Unversity Hospitals

  PRINCIPAL INVESTIGATOR

• Luca Marciani

  Nottingham University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: May 3, 2017

Record last verified: 2017-05