Analysing Differences in Glycaemic Control Immediately Post Obesity SurgEry (The ADIPOSE Study)

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.

Conditions

• Obesity

Sponsors & Collaborators

• University Hospitals, Leicester

  collaborator OTHER

• University of Leicester

  lead OTHER

Principal Investigators

• Melanie Davies, MD · University of Leicester

• David Bowrey, MD · Universty Hospitals of Leicester NHS Trust

• Kamlesh Khunti, MD · University of Leicester

• Patrice Carter, PhD · University of Leicester

• Christopher Sutton, MD · University Hospitals, Leicester

• Laura Gray, PhD · University of Leicester

• Emer Brady, PhD · University Hospitals, Leicester

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United Kingdom

Study Locations