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
1 other identifier
observational
21
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2024
CompletedApril 29, 2025
November 1, 2023
2.3 years
September 6, 2021
April 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of VLCD
Changes to liver fat volume due to VLCD as measured with MRI
baseline to +2weeks
Secondary Outcomes (12)
Effects of VLCD on Liver and Pancreas
baseline to +2weeks
Effects of VLCD and bariatric surgery
+2weeks to +6weeks(post surgery)
Effects of VLCD and bariatric surgery
+6weeks(post surgery) to +4months (post surgery)
Effects of VLCD and bariatric surgery
+2weeks to +6weeks (post surgery)
Effects of VLCD and bariatric surgery
+6weeks (post surgery) to +4months (post surgery)
- +7 more secondary outcomes
Study Arms (2)
RYGB
Patients undergoing Roux-en-Y gastric bypass surgery
SG
Patients undergoing Sleeve Gastrecomy surgery
Interventions
Eligibility Criteria
Patients living in and around Derby and Leicester who are attending the bariatric clinic at royal derby hospital.
You may qualify if:
- Listed for RYCG or SG at the royal derby hospital
- BMI\>/=18
- Type 2 diabetes
- Ability to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- University of Leicestercollaborator
- Medical Research Councilcollaborator
- International Stem Cell Forumcollaborator
- University Hospitals of Derby and Burton NHS Foundation Trustcollaborator
Study Sites (1)
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny Gowland
University of Nottingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2021
First Posted
October 25, 2021
Study Start
July 1, 2022
Primary Completion
October 28, 2024
Study Completion
October 28, 2024
Last Updated
April 29, 2025
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share