Effects of VLCD and Bariatric Surgery in Patients With Type 2 Diabetes (BARIATRICMRI)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; NAFLD; Type2 Diabetes
• Intervention / Treatment: Procedure: Bariatric Surgery

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients living in and around Derby and Leicester who are attending the bariatric clinic at royal derby hospital.

Description

Inclusion Criteria:

• Listed for RYCG or SG at the royal derby hospital
• BMI>/=18
• Type 2 diabetes
• Ability to give informed consent

Exclusion Criteria:

1. If they are not suitable for either RYGB or SG as determined by the MDT meeting
2. BMI>60
3. Liver cirrhosis.
4. Participants will be excluded if they are deemed unfit for an MRI via the standard safety screening form.
5. 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.
6. Participation in other research projects

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RYGB; Patients undergoing Roux-en-Y gastric bypass surgery	Procedure: Bariatric Surgery; No study interventions
SG; Patients undergoing Sleeve Gastrecomy surgery	Procedure: Bariatric Surgery; No study interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of VLCD	Changes to liver fat volume due to VLCD as measured with MRI	baseline to +2weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	+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	+6weeks(post surgery) to +4months (post surgery)
Effects of VLCD and bariatric surgery	Changes to Liver ATP flux as measured using MRS	+2weeks to +6weeks (post surgery)
Effects of VLCD and bariatric surgery	Changes to Liver ATP flux as measured using MRS	+6weeks (post surgery) to +4months (post surgery)
Difference between surgery types (RYGB Vs SG)	Changes to Liver ATP flux as measured using MRS	+6weeks (post surgery)
Effects of different surgery types (RYGB Vs SG) on Liver ATP flux	Changes to Liver ATP flux as measured using MRS	+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	+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	+6 weeks (post surgery)
Effects of VLCD and bariatric surgery	Bile Acid Quantification	0 to +2weeks
Effects of VLCD and bariatric surgery	Bile Acid Quantification	+6weeks post surgery
Effects of VLCD and bariatric surgery	Bile Acid Quantification	4months post surgery

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: Medical Research Council; University of Leicester; University Hospitals of Derby and Burton NHS Foundation Trust; International Stem Cell Forum
• Investigators: Principal Investigator: Penny Gowland, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: MRI; VLCD; Bariatric Surgery; MRS
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 21047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No