A Prospective Pilot Study Investigating the Effects of Bariatric Surgery on Measures of Glycaemic Control and Incretin Levels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Leicester
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Glycaemic shift
Study Overview
Brief Summary
It is well established that bariatric (weightloss) surgery affords considerable improvement in glycaemic control (control of blood sugar), and in many cases may lead to a complete resolution of type 2 diabetes. However, the mechanisms underlying these changes are yet to be elucidated and no research project to date has attempted to characterise changes in glycaemic control sooner than 3 days post surgery.
The primary objective of this study is to characterise changes in glycaemic control in individuals immediately following such surgery for a period of five days. Participants will be fitted with a continuous blood glucose measurement system (CGMS) prior to leaving theatre, which electronically records their blood glucose concentration every minute for up to five days. Upon returning the device each participant will undergo a standard meal test and have a small blood sample taken at 30 minute intervals (0-120 minutes) for the quantification of incretins (gut hormones involved in medium term control of blood sugar) insulin, glucose and appetite hormones.
These measurements will be compared to those collected at the baseline session, three weeks prior to the patient's surgery. Additional baseline visit measurements include: fasting lipid profile, insulin concentration, blood glucose concentration, HBA1C (long term blood glucose measurement), blood pressure, height, weight, waist circumference, and an oral glucose tolerance test (OGTT) and medical and family history.
All patients will be followed up twelve weeks post surgery, during which, all baseline measurements will be repeated.
Detailed Description
The primary objective of the proposed study is to track glycaemic control in real-time using a state of the art continuous blood glucose monitoring system (CGMS) immediately after surgery to pin-point the exact timing of improvements in glycaemic control. The main secondary objective will be the association between change in glycaemic control and change in the levels of incretin hormones (GLP-1 and GIP).
Study Design
This is a prospective pilot study investigating the effects of bariatric surgery on measures of glycaemic control and incretin levels.
Aims
We aim to:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •No active psychotic illness
- •On the waiting list for bariatric surgery at the Leicester Royal Infirmary and thus meeting the local eligibility criteria for this procedure
Exclusion Criteria
- •< 18 years of age
- •Active psychotic illness
- •Receiving either GLP1 analogue or DPPIV inhibitor therapy
- •History of dug or alcohol dependancy
- •History of poorly controlled/severe mental health problems
- •Presence of any comorbidities contraindicative of abdominal surgery or anaesthesia (American Society of Anaesthesiology grade 4, certain grade 3)
Outcomes
Primary Outcomes
Glycaemic shift
Time Frame: Baseline - 12 weeks post surgery
The primary outcome is time taken for a glycaemic shift to be observed, as measured by CGMS. This is the mean proportion (%) of time spent either above (≥10mmol/l), below (≤3.1mmol/l) or within (3.2-9.9mmol/l) our predefined glycaemic ranges will be calculated for each participant over the recording period and adjusted for 24 hours. A glycaemic shift in this context is defined as a statistically (p\<0.05) significant reduction or increase in the proportion of time spent within a glycaemic range i.e. shift from hyperglycaemic to normoglycaemic range.
Secondary Outcomes
- Change in subjective appetite(Baseline to 12 weeks post surgery)
- Change in subjective palatability(Baeline to 12 weeks post sugery)
- Change in appetite via VAS(Baseline to 12 weeks post surgery)
- Change in GLP-1 Profile(Baseline to 12 weeks post surgery)
- Change in GIP profile(Baseline to 12 weeks post surgery)
- Change in insulin profile(Baseline to 12 weeks post surgery)
- Change in FPG(Baseline to 12 weeks post surgery)
- Change in number of hypoglycaemic events(Baseline to 12 weeks post surgery)
- Change in duration of hypoglycaemic events(Baseline to 12 weeks post surgery)
- Change in palatability via VAS(Baseline to 12 weeks post surgery)
- Change in number of hyperglycaemic events(Baseline to 12 weeks post surgery)
- Change in duration of hyperglycaemic events(Baseline to 12 weeks post surgery)
- Change in HbA1c(Baseline to 12 weeks post surgery)
- Change in MAGE(Baseline to 12 weeks post surgery)
- Change in 2h glucose(Baseline to 12 weeks post surgery)