- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528187
Magnetic Resonance Imaging in Obesity
To Investigate the Effect of Therapeutic Interventions Used in the Treatment of Obesity on Organ and Total Body Fat Measured Using MRI.
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).
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- University College London Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient Cohort 1
|
MRI scan (not involving ionising radiation) The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
Student researcher or research nurses to take consent.
Consent will be taken in the obesity clinic or radiology departments.
|
Patient Cohort 2
|
MRI scan (not involving ionising radiation) The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
Student researcher or research nurses to take consent.
Consent will be taken in the obesity clinic or radiology departments.
|
Controls
|
MRI scan (not involving ionising radiation) The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
Student researcher or research nurses to take consent.
Consent will be taken in the obesity clinic or radiology departments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/0703
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
University of EdinburghActive, not recruiting
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupUnknownBreast Cancer | BIRADS 3 | BIRADS 4 | BIRADS 5United States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States