Magnetic Resonance Imaging in Obesity

NCT03528187 | Completed

• 1 other identifier: 17/0703
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity and its related conditions account for up to 5%of all health care spending in the UK and this is expected to double by 2030. Following weight loss, significant improvement in these obesity-related illnesses has been reported. However, there is limited understanding of how these improvements happen and in particular, little dedicated work has been done using imaging in the obese population to look at the effects of treatment. Magnetic resonance imaging (MRI) is an imaging technique that allows assessment of fat concentration and volume without the use of ionising radiation. It is safe, non-invasive and well-tolerated by most patients. There are several MRI imaging techniques that be can used for fat quantification. These include MR spectroscopy and Dixon methods with measurement of fat fraction. These techniques measure the fat in the body organs and also the fat in the abdomen and skin. Recent technical developments mean that the whole body can be scanned relatively quickly (typically 30-40 minutes).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• The effects of obesity treatments on individual organ using MRI

  Measures are fat fraction in individual organs before and after therapeutic interventions

  15 years

Secondary Outcomes (1)

• Imaging measure of individual organ with metabolic markers of disease collected as part of usual care or parallel research studies.

  15 years

Study Arms (3)

Patient Cohort 1

* Age 18 or over * BMI greater than or equal to 30 (greater than or equal to 27.5 for patients of Asian origin) * Due to undergo or referred for a formal treatment intervention for obesity (lifestyle modifications \[dietary change, behavioural therapy, increased physical activity\], surgical intervention or pharmacological treatment) as part of their usual clinical care * Informed written consent * Able to tolerate MRI

Other: MRI; Other: Written Consent

Patient Cohort 2

* Age 18 or over * Attending weight management service at UCLH * Informed written consent * Able to tolerate MRI

Other: MRI; Other: Written Consent

Controls

* Age 18 or over * BMI less than 25 * Informed written consent * Able to tolerate MRI

Other: MRI; Other: Written Consent

Interventions

MRI OTHER

MRI scan (not involving ionising radiation) The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher

Controls; Patient Cohort 1; Patient Cohort 2

Written Consent OTHER

Student researcher or research nurses to take consent. Consent will be taken in the obesity clinic or radiology departments.

Controls; Patient Cohort 1; Patient Cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited by suitably trained members of the research team on the study delegation log including research fellows, nurses, surgeons and endocrinologists working in a tertiary bariatric referral centre at UCLH on a person-to-person basis.

You may qualify if:

• Age 18 or over
• BMI greater than or equal to 30
• Due to undergo or referred for a formal treatment intervention for obesity, as part of their usual clinical care.
• Informed consent
• Cohort 2
• Age 18 or over
• Attending the weight management service at UCLH
• Informed consent
• Controls
• Age 18 or over
• BMI less than 25
• Informed consent

You may not qualify if:

• Absolute contraindication to MRI scan (e.g. metal foreign object)
• Unable to tolerate MRI scan (e.g. due to claustrophobia)
• MRI bore size inadequate to accommodate the patient
• Previous weight loss surgery (e.g. gastric band, gastric bypass, sleeve gastrectomy) \[Cohort 1 only\]
• Unable to give consent
• Pregnancy

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, United Kingdom

Location

Related Publications (4)

• Reeder SB, Cruite I, Hamilton G, Sirlin CB. Quantitative Assessment of Liver Fat with Magnetic Resonance Imaging and Spectroscopy. J Magn Reson Imaging. 2011 Oct;34(4):729-749. doi: 10.1002/jmri.22775. Epub 2011 Sep 16.

  PMID: 22025886 BACKGROUND

• Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

  PMID: 17715408 BACKGROUND

• Hernando D, Sharma SD, Aliyari Ghasabeh M, Alvis BD, Arora SS, Hamilton G, Pan L, Shaffer JM, Sofue K, Szeverenyi NM, Welch EB, Yuan Q, Bashir MR, Kamel IR, Rice MJ, Sirlin CB, Yokoo T, Reeder SB. Multisite, multivendor validation of the accuracy and reproducibility of proton-density fat-fraction quantification at 1.5T and 3T using a fat-water phantom. Magn Reson Med. 2017 Apr;77(4):1516-1524. doi: 10.1002/mrm.26228. Epub 2016 Apr 15.

  PMID: 27080068 BACKGROUND

• Takahara T, Imai Y, Yamashita T, Yasuda S, Nasu S, Van Cauteren M. Diffusion weighted whole body imaging with background body signal suppression (DWIBS): technical improvement using free breathing, STIR and high resolution 3D display. Radiat Med. 2004 Jul-Aug;22(4):275-82.

  PMID: 15468951 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 17, 2018
• Study Start: May 31, 2018
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

GB (1)