ObesityNCT03528187
Magnetic Resonance Imaging in Obesity
An observational study of Obesity, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MRI and Written Consent
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2018to 6 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- Attending the weight management service at UCLH
- Informed consent
- Controls
- Age 18 or over
- BMI less than 25
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Obesity
- Being tested
- MRI, Written Consent
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI scan (not involving ionising radiation)
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
Written ConsentOther
Student researcher or research nurses to take consent. Consent will be taken in the obesity clinic or radiology departments.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: MRI; Other: Written Consent | |
| Controls | * Age 18 or over
* BMI less than 25
* Informed written consent
* Able to tolerate MRI Receives: Other: MRI; Other: Written Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of obesity treatments on individual organ using MRI
Measures are fat fraction in individual organs before and after therapeutic interventions
Measured: 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.
Measures are associations between patterns of organ fat deposition and metabolic phenotypes, before and after treatment.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start31 May 2018
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528187
- Sponsor's protocol ID
- 17/0703
- Status last verified
- Oct 2023
- First submitted
- 27 Apr 2018
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22025886Sjostrom 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.
PubMed 17715408Hernando 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.
PubMed 27080068Takahara 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.
PubMed 15468951
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect of Therapeutic Interventions Used in the Treatment of Obesity on Organ and Total Body Fat Measured Using MRI.
- ClinicalTrials.gov ID
- NCT03528187
- Acronym / sponsor ID
- 17/0703
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Cohort 1 | – | Other: MRI, Other: Written Consent* 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 |
| Patient Cohort 2 | – | Other: MRI, Other: Written Consent* Age 18 or over * Attending weight management service at UCLH * Informed written consent * Able to tolerate MRI |
| Controls | – | Other: MRI, Other: Written Consent* Age 18 or over * BMI less than 25 * Informed written consent * Able to tolerate MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI scan (not involving ionising radiation) The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher | Other | Controls, Patient Cohort 1, Patient Cohort 2 |
| Written ConsentStudent researcher or research nurses to take consent. Consent will be taken in the obesity clinic or radiology departments. | Other | Controls, Patient Cohort 1, Patient Cohort 2 |
Primary outcome
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
1 secondary outcome
Imaging measure of individual organ with metabolic markers of disease collected as part of usual care or parallel research studies.
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Background: PubMed 22025886Reeder 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.
- Background: PubMed 17715408Sjostrom 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.
- Background: PubMed 27080068Hernando 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.
- Background: PubMed 15468951Takahara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of obesity treatments on individual organ using MRI (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528187, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.