NCT05092399Completed
Effects of VLCD and Bariatric Surgery in Patients With Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 21 (actual)
- First submitted
- 6 Sept 2021
- Start date
- 1 Jul 2022
- Primary completion date
- 28 Oct 2024
- Lead sponsor
- University of Nottingham
- NCT number
- NCT05092399
What you commit to
- Study type: Observational
- Participants enrolled: 21
- From 1 Jul 2022 to the primary completion date, 28 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- Listed for RYCG or SG at the royal derby hospital
- BMI\>/=18
- Type 2 diabetes
- Ability to give informed consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.