Observational Study on Glucose Variability after Metabolic Surgery
Research type
Research Study
Full title
Observational Study on Glucose Variability after Metabolic Surgery
IRAS ID
285211
Contact name
Tricia Tan
Contact email
Sponsor organisation
RGIT, Imperial College London and Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a longitudinal observational study of two participant groups:
- Study 1: Metabolic surgery: Patients attending the Imperial Weight Centre who are planning to have metabolic surgery (Roux-en-Y gastric bypass, Sleeve Gastrectomy, Mini Gastric Bypass). Up to 18 participants per surgical type will be recruited (total 54).
– Study 2: Metabolic Surgery and Pregnancy: Women who have had metabolic surgery before and who are planning to conceive. Up to 18 participants per surgical type will be recruited (total 54).
The duration will be up to two years for each subject.
The participants will undergo a baseline Continuous Glucose Monitoring study using a validated glucose sensor system (e.g. Dexcom G6) for between 7-14 days.
This involves:
1. Painless application of a sensor and transmitter to the skin of the abdomen.
2. Carrying receiver device in close proximity to the transmitter at all times.
3. Removal of sensor and transmitter after completion of the study and return of the receiver to the study team.
This will be repeated at various time points for both groups.
The aim of the study is to characterize the phenomenon of glucose variability (GV) in patients undergoing metabolic surgery and in women who have had metabolic surgery and who are either pregnant or planning to conceive.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0038
Date of REC Opinion
1 Feb 2021
REC opinion
Favourable Opinion