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Magnetic Resonance Imaging in Obesity

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528187
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

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).


Condition or disease Intervention/treatment
Obesity Other: MRI Other: Written Consent

Detailed Description:

Obesity and its related conditions are a significant cause of death and ill health. There have been a number of studies showing that weight loss, in particular that achieved by bariatric (weight-loss) surgery, results in improvement in obesity-related conditions such as type 2 diabetes mellitus. A large case-control study demonstrated a mean weight loss of 23.4% by 2 years and sustained mean weight loss of 16.1% compared to matched controls. 72% of patients with type 2 diabetes were in remission at 2 years and this was 36% at 10 years. Bariatric surgery also results in recovery from lipid disturbances with 62% of patients demonstrating normalisation of hypertriglyceridaemia (high fat levels in the blood) at 2 years and 46% at 10 years. There is also a smaller cohort of patients who, despite significant weight loss, do not experience remission of their obesity-related comorbidities.

The mechanisms for the improvement in obesity-related ill health are not well understood and little dedicated work has been undertaken on imaging in the obese population before and after treatment. For example, increased fat content in the liver, bone and pancreas is well described in obesity but it is unclear whether response to treatment is uniform across all these organs, or if there are specific patients who would benefit from additional or alternative interventions for hard to treat organ fat. The effect on remaining organ fat following treatment on clinical parameters such as body shape, and metabolism, is also unknown. Furthermore, it is not known if there are certain patterns of organ fat which may respond better to one type of therapy such as surgery compared to medical treatment for example, and choosing the best treatment for patients may be improved by a better understanding of organ fat. The effect of obesity on bone structure and strength, bone hormonal activity and metabolism is poorly understood. Finally, the link, if any, between patterns of organ fat and patients' genes, body shape and metabolism before and after treatment and is also unclear.

Treatment options for obesity continue to develop. Several novel medical (non-surgical) treatments for obesity have become available and the number of patients undergoing bariatric surgery continues to increase. There is therefore need to understand the mechanisms behind both weight loss (and the contribution of individual organs to this) and the improvement in obesity-related conditions. By gaining greater understanding of this, we aim to better predict outcomes for individual patients and better select the most appropriate treatment for them.

There has been recent research into MRI as a method of quantifying fat in abdominal organs such as the liver and pancreas. MRI has the advantages of being non-invasive (for example when compared to liver biopsy) and does not use ionising radiation unlike other imaging modalities.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: To Investigate the Effect of Therapeutic Interventions Used in the Treatment of Obesity on Organ and Total Body Fat Measured Using MRI.
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : May 1, 2028
Estimated Study Completion Date : May 1, 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
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

MRI scan (not involving ionising radiation)

The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher


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

Patient Cohort 2
  • Age 18 or over
  • Attending weight management service at UCLH
  • Informed written consent
  • Able to tolerate MRI
Other: MRI

MRI scan (not involving ionising radiation)

The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher


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

Controls
  • Age 18 or over
  • BMI less than 25
  • Informed written consent
  • Able to tolerate MRI
Other: MRI

MRI scan (not involving ionising radiation)

The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher


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




Primary Outcome Measures :
  1. The effects of obesity treatments on individual organ using MRI [ Time Frame: 15 years ]
    Measures are fat fraction in individual organs before and after therapeutic interventions


Secondary Outcome Measures :
  1. Imaging measure of individual organ with metabolic markers of disease collected as part of usual care or parallel research studies. [ Time Frame: 15 years ]
    Measures are associations between patterns of organ fat deposition and metabolic phenotypes, before and after treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Cohort 1

Inclusion Criteria:

  • 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

Inclusion Criteria:

  • Age 18 or over
  • Attending the weight management service at UCLH
  • Informed consent

Controls

  • Age 18 or over
  • BMI less than 25
  • Informed consent

Exclusion Criteria for all cohorts:

  • 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

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): NCT03528187


Contacts
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Contact: Naomi Sakai, MRCS MA MB BChir 0203447 9044 naomi.sakai@nhs.net
Contact: Katerina Soteriou, BSc katerina.soteriou@nhs.net

Locations
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United Kingdom
University College London Hospital Recruiting
London, United Kingdom
Contact: Naomi Sakai         
Sponsors and Collaborators
University College, London
Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03528187    
Other Study ID Numbers: 17/0703
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight