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

NCT04343040 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

carbohydrate supplement (Preload™)

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.

PROCEDURE

6 hours of preoperative fasting

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

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Robert Caiazzo, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-12-01
Completion
2024-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04343040 on ClinicalTrials.gov