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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Effects of VLCD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Listed for RYCG or SG at the royal derby hospital
- •BMI>/=18
- •Type 2 diabetes
- •Ability to give informed consent
排除标准
- •If they are not suitable for either RYGB or SG as determined by the MDT meeting
- •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
结局指标
主要结局
Effects of VLCD
时间窗: baseline to +2weeks
Changes to liver fat volume due to VLCD as measured with MRI
次要结局
- Effects of VLCD on Liver and Pancreas(baseline to +2weeks)
- Effects of VLCD and bariatric surgery(4months post surgery)
- Effects of different surgery types (RYGB Vs SG) on Liver ATP flux(+4months (post surgery))
- Difference between surgery types (RYGB Vs SG)(+6 weeks (post surgery))
- Effects of different surgery types (RYGB Vs SG) on Organ fat content(+4months (post surgery))