Bariatric Surgery Candidate Clinical Trial
— PERISURG-CGMOfficial title:
Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients Submitted to Bariatric Surgery and Receiving Pre-operative Carbohydrate Loading in Comparison With Standard 6h Fasting - A Single Center, Open-label, Randomized Pilot Study
The recent use of a pre-operative carbohydrate loading compared to fasting has been shown to improve the early recovery after surgical procedures by reducing the profound stress response following surgery and allowing a better postoperative blood glucose regulation by lowering insulin resistance. The responsible mechanisms of T2D remission after bariatric surgery are not completely understood and guidelines for the early management of T2D and GI following bariatric surgery are lacking, resulting in highly variable postoperative glucose control. No other study has yet investigated the effect of preoperative carbohydrate loading on glucose control the first days after the bariatric surgery in patients who have poor glycemic control
Status | Not yet recruiting |
Enrollment | 76 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Bariatric surgery planned (RYGB or SG) - BMI at least 35 kg/m2 with comorbidity that can be improved after surgery(including cardiovascular disease including high blood pressure, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, disabling osteoarticular disease, steatohepatitis non-alcoholic) - Glucose Intolerance as defined by the American Diabetes Association (ADA Diabetes Care 2017) - Negative pregnancy test - Informed consent - Patient with social insurance Exclusion Criteria: - Patients receiving insulin therapy - Previous bariatric surgery - Definite symptoms of gastroparesis assessed by Gastroparesis Cardinal Symptoms Index (GCSI)*. Values of score = 1.90 will be chosen as definite symptoms of gastroparesis. - Pregnant or breastfeeding woman, persons deprived of their liberty, persons under guardianship or trusteeship |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital, Lille |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean blood glucose level of CGM over 24-h period beginning the day after surgery in patients receiving pre-operative carbohydrate loading in comparison with standard 6h fasting | mean blood glucose level over 24h at D1 after surgery, as assessed by CGM | Day 1 after surgery | |
Secondary | mean blood glucose value | mean blood glucose level over 24h, as assessed by CGM, during preoperative period, day2 and day 3 after surgery, day4 to 6 after surgery and at 3 months | preoperative, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | post prandial peak glucose (Gmax) | post prandial peak glucose (Gmax) will be assessed by CGM over 24h period, during preoperative period, day2 and day 3 after surgery, day4 to 6 after surgery and at 3 months | preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | the time spent in hyperglycemic range (> 12 mmol / L) | the time spent in hyperglycemic range will be assessed by CGM over 24h period, during preoperative period, day2 and day 3 after surgery, day4 to 6 after surgery and at 3 months | preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | time spent in hypoglycemic range (<2.4 mmol / L) | the time spent in hypoglycemic range (<2.4 mmol / L)will be assessed by CGM over 24h period, during preoperative period, day2 and day 3 after surgery, day4 to 6 after surgery and at 3 months | preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | total area under the glucose curve (AUC20) | total area under the glucose curve (AUC20) will be calculated using CGM data over 24h period, during preoperative period, day2 and day 3 after surgery, day4 to 6 after surgery and at 3 months | preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | glycemic instability as measured by standard deviation of differences in values of glucose separated by a number of hours (between 1 and 24 hours) (Continuous overall net glycemic action: CONGA). | glycemic instability as measured by standard deviation of differences in values of glucose separated by a number of hours (between 1 and 24 hours) (Continuous overall net glycemic action: CONGA) will be calculated using CGM data over 24h period, during preoperative period, day2 and day 3 after surgery, day4 to 6 after surgery and at 3 months | preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | Rate of patients wit blood glucose levels within a target range (120 to 180 mg / dL [6.67 to 10 mmol / L]) during the perioperative period | rate of patients with blood glucose level within a larger range on CGM values | preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery | |
Secondary | Length of hospital stays after surgery | regarding the initial bariatric procedure | at 1 month after surgery | |
Secondary | Rate of early surgical perioperative complications | within the 30 days after surgery | at 1 month after surgery | |
Secondary | Rate of patients needing antibiotic therapy | within the 30 days after surgery | at 1 month after surgery | |
Secondary | Rate of patients needing reoperation | within the 30 days after surgery | at 1 month after surgery | |
Secondary | Rate of patients normoglycemic at 3 months, defined as blood glucose below 5.5mMol/L and HbA1c of less than 6% in the absence of any antidiabetic medication | rate of normoglycemic patients | at 3 months after surgery |
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