Type2 DiabetesBARIATRICMRINCT05092399
Effects of VLCD and Bariatric Surgery in Patients With Type 2 Diabetes
An observational study of Type2 Diabetes and NAFLD, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The investigators are therefore interested to explore the effects of VLCD and different bariatric surgery procedures to changes in the physical deposition of fat in organs which regulate glucose metabolism (i.e. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2 Diabetes, NAFLD, Obesity
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 28 Oct 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living in and around Derby and Leicester who are attending the bariatric clinic at royal derby hospital.
Who may be able to join
- Listed for RYCG or SG at the royal derby hospital
- BMI>/=18
- Type 2 diabetes
- Ability to give informed consent
Who cannot join
- If they are not suitable for either RYGB or SG as determined by the MDT meeting
- BMI>60
- Liver cirrhosis.
- Participants will be excluded if they are deemed unfit for an MRI via the standard safety screening form.
- Participants will be excluded if their waist circumference is too large for them to safely fit inside the bore of the MRI with surface coils added.
- Participation in other research projects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effects of Very Low-Calorie Diet (VLCD), Roux-En-Y-Gastric Bypass and Sleeve Gastrectomy on Pancreatic, Liver, Muscle and Heart Fat Deposition and Metabolism in People With Type 2 Diabetes: An MRI Study
The investigators are therefore interested to explore the effects of VLCD and different bariatric surgery procedures to changes in the physical deposition of fat in organs which regulate glucose metabolism (i.e. in the liver, pancreas, muscle) in the earlier (6 weeks) and intermediate (4 months) period after bariatric surgery, where rate of weight loss at this stage are similar between the two procedures. Increased understanding of the changes in these important metabolic organs, will increase the investigators' understanding of mechanism of diabetes remission following bariatric surgery, their effects on weight loss or changes in gut hormones levels. Magnetic Resonance imaging (MRI) and Magnetic Resonance spectroscopy (MRS) are non-invasive, non-ionising techniques. MRI can be used to investigate the body's physiology and MRS can be used to investigate the body's metabolic processes, so by combining these two methods the investigators are able to investigate the process of fat reduction and diabetes remission post gastric surgery without performing any secondary invasive procedures The purpose of this project is to investigate the effects of a Very Low Calorie Diet (VLCD) followed by two different bariatric surgical procedures, Roux-en-Y Gastric Bypass (RYGB) and Sleeve gastrectomy (SG) on skeletal muscle, liver and pancreatic fat deposition, ATP flux as well as cardiac function.
Read the detailed description
There are NO research interventions, this study is observing a patient's response to clinical interventions. The below describes the investigators methods of observation.
Screening:
Participants who are listed for surgery by the Bariatric surgical Tier 4 MDT team will be approached by one of the main care team who may also be a member of the research team during the ERAS session (Enhanced Recovery After Surgery) approximately 6 months before surgery. If the participants wish to partake in the study the will be then screened for ability and willingness to undergo MRI in order to prevent any wasting of the patients time and prevent unnecessary data storage. If eligible and consent is provided, their details will be kept by the research team to be contacted for further appointment to attend the investigators University of Nottingham (UoN) research unit based at the Royal Derby Hospital.
There are 2 main arms to the study, consists of 2 arms, patients undergoing RYGB (group 1) and Patients undergoing SG (group 2) Within these groups there are category A and B participants.
Category A - Primary Study - Participants who will be used to investigate the primary and secondary outcomes.
Category B - Exploratory sub-study - Participants will be used to investigate the Primary outcome but also as a pilot set of data for cardiac measures.
At all category A sessions Participants will be asked to attend a session at the Sir Peter Mansfield Imaging Centre (SPMIC) on the UoN main campus.
The participants will receive an MRI and MRS scan, a Blood Test and a liquid mixed meal test at every session. The mixed meal test is not apart of routine care, in this study it shall be used to examine the change in participants response to a meal after each clinical intervention (VLCD and Surgery). Blood samples will be taken by a trained member of staff and transferred to the Royal Derby Hospital for testing, this is to obtain Glucose, Ghrelin, C-peptide, glucagon and total and intact glucagon-like peptide-1 (GLP-1).
Participants in category B will be asked to attend sessions at the SPMIC. And will only receive MRI and MRS scans.
Session 1:
A member of the research team will reach out to the patient 2 weeks prior to the commencement of their VLCD in order to confirm the participants are still interested in participating, book in the first study session and answer any questions the participants may have.
Session 2:
Between 3 and 1 day prior to the commencement of the VLCD.
Category A:
The MRI protocol for this session physiology scans of the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy performed on the Liver. Participants will be in the scanner for no longer than 1 hour.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton and Phosphorus MR Spectroscopy (MRS). Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours.
Session 3:
Between 3 and 1 day prior to the Participants Bariatric Surgery.
Category A:
The MRI protocol for this session is physiology scans for the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy and a 31P (phosphorous) spectroscopy performed on the Liver. Basic. Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton and Phosphorus MR Spectroscopy (MRS). Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours
Surgery:
Roux-en-Y Gastric Bypass (RYGB): Follows standard clinical practice. Sleeve Gastrectomy (SG): Follows standard clinical practice.
Session 4:
6 weeks post Bariatric Surgery.
Category A:
The MRI protocol for this session is physiology scans of the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy and a 31P (phosphorous) spectroscopy performed on the Liver. Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton MR Spectroscopy (MRS). Participants will be in the scanner for no longer than 1 hour.
Session 5:
16 weeks post Bariatric Surgery.
Category A:
The MRI protocol for this session is physiology scans of the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy on the Liver. Participants will be in the scanner for no longer than 1 hour.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton MR Spectroscopy (MRS). Participants will be in the scanner for no longer than 1 hour.
- Conditions
- Type2 Diabetes, NAFLD, Obesity
- Being tested
- Bariatric Surgery
- Keywords
- VLCD, Bariatric Surgery, MRI, MRS
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
No study interventions
| Study group | Role | What they receive |
|---|---|---|
| RYGB | Patients undergoing Roux-en-Y gastric bypass surgery Receives: Procedure: Bariatric Surgery | |
| SG | Patients undergoing Sleeve Gastrecomy surgery Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of VLCD
Changes to liver fat volume due to VLCD as measured with MRI
Measured: baseline to +2weeks
Secondary outcomes (12)
Effects of VLCD on Liver and Pancreas
Changes to live and pancreatic fat as measured using MRI and MRS as measured as percentage fat in tissue.
Measured: baseline to +2weeks
Effects of VLCD and bariatric surgery
Changes to Skeletal muscle liver and pancreatic fat as measured using MRI and MRS as measured as percentage fat in tissue.
Measured: +2weeks to +6weeks(post surgery)
Effects of VLCD and bariatric surgery
Changes to Skeletal muscle, liver and pancreatic fat as measured using MRI and MRS as measured as percentage fat in tissue
Measured: +6weeks(post surgery) to +4months (post surgery)
Effects of VLCD and bariatric surgery
Changes to Liver ATP flux as measured using MRS
Measured: +2weeks to +6weeks (post surgery)
Effects of VLCD and bariatric surgery
Changes to Liver ATP flux as measured using MRS
Measured: +6weeks (post surgery) to +4months (post surgery)
Difference between surgery types (RYGB Vs SG)
Changes to Liver ATP flux as measured using MRS
Measured: +6weeks (post surgery)
Effects of different surgery types (RYGB Vs SG) on Liver ATP flux
Changes to Liver ATP flux as measured using MRS
Measured: +4months (post surgery)
Effects of different surgery types (RYGB Vs SG) on Organ fat content
Changes to skeletal muscle, liver and pancreatic fat as measured using MRI and MRS as measured as percentage fat content of tissue
Measured: +4months (post surgery)
Difference between surgery types (RYGB Vs SG)
Changes to Skeletal muscle, liver and pancreatic fat as measured using MRI and MRS as measured as percentage fat content of tissue
Measured: +6 weeks (post surgery)
Effects of VLCD and bariatric surgery
Bile Acid Quantification
Measured: 0 to +2weeks
Effects of VLCD and bariatric surgery
Bile Acid Quantification
Measured: +6weeks post surgery
Effects of VLCD and bariatric surgery
Bile Acid Quantification
Measured: 4months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jul 2022
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, Medical Research Council, International Stem Cell Forum, University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Penny Gowland, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092399
- Sponsor's protocol ID
- 21047
- Acronym
- BARIATRICMRI
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Very Low-Calorie Diet (VLCD), Roux-En-Y-Gastric Bypass and Sleeve Gastrectomy on Pancreatic, Liver, Muscle and Heart Fat Deposition and Metabolism in People With Type 2 Diabetes: An MRI Study
- ClinicalTrials.gov ID
- NCT05092399
- Acronym / sponsor ID
- BARIATRICMRI / 21047
- Conditions
- Type2 Diabetes, NAFLD, Obesity
- Keywords
- VLCD, Bariatric Surgery, MRI, MRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of Leicester, Medical Research Council, International Stem Cell Forum, University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 25 Oct 2021 (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.
The investigators are therefore interested to explore the effects of VLCD and different bariatric surgery procedures to changes in the physical deposition of fat in organs which regulate glucose metabolism (i.e. in the liver, pancreas, muscle) in the earlier (6 weeks) and intermediate (4 months) period after bariatric surgery, where rate of weight loss at this stage are similar between the two procedures. Increased understanding of the changes in these important metabolic organs, will increase the investigators' understanding of mechanism of diabetes remission following bariatric surgery, their effects on weight loss or changes in gut hormones levels. Magnetic Resonance imaging (MRI) and Magnetic Resonance spectroscopy (MRS) are non-invasive, non-ionising techniques. MRI can be used to investigate the body's physiology and MRS can be used to investigate the body's metabolic processes, so by combining these two methods the investigators are able to investigate the process of fat reduction and diabetes remission post gastric surgery without performing any secondary invasive procedures The purpose of this project is to investigate the effects of a Very Low Calorie Diet (VLCD) followed by two different bariatric surgical procedures, Roux-en-Y Gastric Bypass (RYGB) and Sleeve gastrectomy (SG) on skeletal muscle, liver and pancreatic fat deposition, ATP flux as well as cardiac function.
Detailed description
There are NO research interventions, this study is observing a patient's response to clinical interventions. The below describes the investigators methods of observation.
Screening:
Participants who are listed for surgery by the Bariatric surgical Tier 4 MDT team will be approached by one of the main care team who may also be a member of the research team during the ERAS session (Enhanced Recovery After Surgery) approximately 6 months before surgery. If the participants wish to partake in the study the will be then screened for ability and willingness to undergo MRI in order to prevent any wasting of the patients time and prevent unnecessary data storage. If eligible and consent is provided, their details will be kept by the research team to be contacted for further appointment to attend the investigators University of Nottingham (UoN) research unit based at the Royal Derby Hospital.
There are 2 main arms to the study, consists of 2 arms, patients undergoing RYGB (group 1) and Patients undergoing SG (group 2) Within these groups there are category A and B participants.
Category A - Primary Study - Participants who will be used to investigate the primary and secondary outcomes.
Category B - Exploratory sub-study - Participants will be used to investigate the Primary outcome but also as a pilot set of data for cardiac measures.
At all category A sessions Participants will be asked to attend a session at the Sir Peter Mansfield Imaging Centre (SPMIC) on the UoN main campus.
The participants will receive an MRI and MRS scan, a Blood Test and a liquid mixed meal test at every session. The mixed meal test is not apart of routine care, in this study it shall be used to examine the change in participants response to a meal after each clinical intervention (VLCD and Surgery). Blood samples will be taken by a trained member of staff and transferred to the Royal Derby Hospital for testing, this is to obtain Glucose, Ghrelin, C-peptide, glucagon and total and intact glucagon-like peptide-1 (GLP-1).
Participants in category B will be asked to attend sessions at the SPMIC. And will only receive MRI and MRS scans.
Session 1:
A member of the research team will reach out to the patient 2 weeks prior to the commencement of their VLCD in order to confirm the participants are still interested in participating, book in the first study session and answer any questions the participants may have.
Session 2:
Between 3 and 1 day prior to the commencement of the VLCD.
Category A:
The MRI protocol for this session physiology scans of the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy performed on the Liver. Participants will be in the scanner for no longer than 1 hour.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton and Phosphorus MR Spectroscopy (MRS). Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours.
Session 3:
Between 3 and 1 day prior to the Participants Bariatric Surgery.
Category A:
The MRI protocol for this session is physiology scans for the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy and a 31P (phosphorous) spectroscopy performed on the Liver. Basic. Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton and Phosphorus MR Spectroscopy (MRS). Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours
Surgery:
Roux-en-Y Gastric Bypass (RYGB): Follows standard clinical practice. Sleeve Gastrectomy (SG): Follows standard clinical practice.
Session 4:
6 weeks post Bariatric Surgery.
Category A:
The MRI protocol for this session is physiology scans of the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy and a 31P (phosphorous) spectroscopy performed on the Liver. Participants will be offered a break after being in the scanner for 1hour with a maximum time in the scanner of 2hours.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton MR Spectroscopy (MRS). Participants will be in the scanner for no longer than 1 hour.
Session 5:
16 weeks post Bariatric Surgery.
Category A:
The MRI protocol for this session is physiology scans of the Chest, Abdomen and Skeletal Muscle (thigh) and MRS is proton spectroscopy on the Liver. Participants will be in the scanner for no longer than 1 hour.
Category B:
Basic Cardiac measures using MRI will be used in planning for Proton MR Spectroscopy (MRS). Participants will be in the scanner for no longer than 1 hour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB | – | Procedure: Bariatric SurgeryPatients undergoing Roux-en-Y gastric bypass surgery |
| SG | – | Procedure: Bariatric SurgeryPatients undergoing Sleeve Gastrecomy surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in and around Derby and Leicester who are attending the bariatric clinic at royal derby hospital.
Key inclusion criteria (4 listed)
- Listed for RYCG or SG at the royal derby hospital
- BMI>/=18
- Type 2 diabetes
- Ability to give informed consent
Key exclusion criteria (6 listed)
- If they are not suitable for either RYGB or SG as determined by the MDT meeting
- BMI>60
- Liver cirrhosis.
- Participants will be excluded if they are deemed unfit for an MRI via the standard safety screening form.
- Participants will be excluded if their waist circumference is too large for them to safely fit inside the bore of the MRI with surface coils added.
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 |
|---|---|---|
| Bariatric SurgeryNo study interventions | Procedure or surgery | RYGB, SG |
Primary outcome
Effects of VLCD
Time frame: baseline to +2weeks
Changes to liver fat volume due to VLCD as measured with MRI
12 secondary outcomes
Effects of VLCD on Liver and Pancreas
Time frame: baseline to +2weeks
Effects of VLCD and bariatric surgery
Time frame: +2weeks to +6weeks(post surgery)
Effects of VLCD and bariatric surgery
Time frame: +6weeks(post surgery) to +4months (post surgery)
Effects of VLCD and bariatric surgery
Time frame: +2weeks to +6weeks (post surgery)
Effects of VLCD and bariatric surgery
Time frame: +6weeks (post surgery) to +4months (post surgery)
Difference between surgery types (RYGB Vs SG)
Time frame: +6weeks (post surgery)
Effects of different surgery types (RYGB Vs SG) on Liver ATP flux
Time frame: +4months (post surgery)
Effects of different surgery types (RYGB Vs SG) on Organ fat content
Time frame: +4months (post surgery)
Difference between surgery types (RYGB Vs SG)
Time frame: +6 weeks (post surgery)
Effects of VLCD and bariatric surgery
Time frame: 0 to +2weeks
Effects of VLCD and bariatric surgery
Time frame: +6weeks post surgery
Effects of VLCD and bariatric surgery
Time frame: 4months post surgery
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 29 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Penny Gowland principal investigator
University of Nottingham
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 Type2 Diabetes and NAFLD, run by University of Nottingham 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 4 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 29 Apr 2025. 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?
Effects of VLCD (time frame: baseline to +2weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2025.