Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients

NCT04343040 | Withdrawn

• 2 other identifiers: 2017_342017-A03320-53
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hyperglycaemia (Diabetic); Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• mean blood glucose value

  preoperative, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery

• post prandial peak glucose (Gmax)

  preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery

• the time spent in hyperglycemic range (> 12 mmol / L)

  preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery

• time spent in hypoglycemic range (<2.4 mmol / L)

  preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery

• total area under the glucose curve (AUC20)

  preoperative, Day1 after surgery, Day2 and Day 3 after surgery, Day 4 to 6 after surgery, 3 months after surgery

Study Arms (2)

perioperative glucose intake

EXPERIMENTAL

glucose intolerant patients with perioperative glucose (carbohydrate supplement (Preload™) intake before Gastric By-Pass or Sleeve Gastrectomy.

Dietary Supplement: carbohydrate supplement (Preload™)

6 hours of preoperative fasting

SHAM COMPARATOR

glucose intolerant patients receiving 6 hours of preoperative fasting before Gastric By-Pass or Sleeve Gastrectomy.

Procedure: 6 hours of preoperative fasting

Interventions

carbohydrate supplement (Preload™) DIETARY_SUPPLEMENT

carbohydrate supplement (Preload™) will be administered 4-hours prior to bariatric surgery (experimental treatment) Preload™ is a neutral-tasting carbohydrate loading drink mix specifically designed for use before elective surgery. Preload is presented in 50g pre-measured sachets which when added to water (400ml) produces a solution with low osmolality.

perioperative glucose intake

6 hours of preoperative fasting PROCEDURE

Standard of care. In this group, patients continue the standard of care treatment before surgery with fasting recommended 6 hours before surgery.

6 hours of preoperative fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert Caiazzo, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 13, 2020
• Study Start: September 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 22, 2026

Record last verified: 2026-05