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Hyperglycaemia (Diabetic)PERISURG-CGMNCT04343040

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

A study testing carbohydrate supplement (Preload™) and 6 hours of preoperative fasting in people with Hyperglycaemia (Diabetic) and Bariatric Surgery Candidate, run by University Hospital, Lille.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carbohydrate supplement (Preload™) and 6 hours of preoperative fasting
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Sep 2022to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official 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

Read the detailed description

Bariatric surgery allows weight loss and obesity related comorbidities remission. In patients with type 2 diabetes (T2D), glucose intolerance (GI) and metabolic syndrome (MS), weight loss surgery improves glucose control more than medications and/or life style intervention. This approach is gaining acceptance even in patients with mild obesity and indications are now rapidly growing. Roux en Y gastric bypass (RYGB) and Sleeve Gastrectomy (SG) the gold standard operations for treating T2D, lower glycemia often very rapidly and sometime profoundly. The responsible mechanisms 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.

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.

Metabolic stress and insulin resistance follow major surgery. The resulting post-operative hyperglycaemia is associated with increased morbidity as well as mortality. In non-diabetic patients, avoiding pre-operative fastening substantially reduces post-operative stress and insulin resistance. A pre-operative carbohydrate load improves post-operative glycaemic control, most likely by inducing endogenous insulin release before the onset of surgery. This sets the metabolic state of the patient in a fed rather than a fasted state at the time of surgery. Metabolic reactions to surgical stress are thereby markedly reduced not only resulting in a reduced risk for hyperglycaemia during post-operative nutrition but also retained lean body mass, improved muscle strength and nitrogen economy.

The oral preparation used is a carbohydrate-rich clear beverage containing mainly polymers of carbohydrates to minimize the osmotic load. The drink, in addition to its metabolic effect, improves patient well-being (thirst, hunger, anxiety) pre-operatively. Oral preload is considered the first element in the surgical pathway to reduce patients' stress with the aim of early return to oral diet, mobility and recovery as soon as possible after surgery and had a significant effect on reducing complications and improving wellbeing.

Patients with GI and T2D are at particular risk of impaired glycaemic control peri-operatively. Most of the studies using pre-operative carbohydrate loading were performed on non-diabetic patients. A considerable number of patients going through bariatric surgery suffer from GI or T2D (respectively 30% and 15% in our experience), this patient group has been denied initially for the pre-operative carbohydrate drink because of fear of slow gastric emptying and impaired glycaemic control. We are aware of only one study that evaluated the suitability for diabetic patients to have preload drinks pre-operatively . Gustafsson et al explored the possibility of providing pre-operative carbohydrate loading in patients with mild T2D without neuropathy or delayed gastric emptying (as autonomic neuropathy is a likely cause of delayed gastric function in diabetes). In this study, T2D patients (n=25) showed no signs of hyperglycaemia. However, the wider spectrum of diabetic patients was not evaluated. Can et al. also evaluated the effects of pre-operative pre-loading in patients with or without insulin resistance. This differed from other studies, which had previously excluded those with known insulin resistance. This study included 34 cholecystectomy or thyroidectomy patients showed that the temporal pattern of plasma glucose in patients with insulin resistance who were given preload drinks pre-operatively was similar to that of patients without insulin resistance. These studies suggest that there might be a benefit without risk of hyperglycaemia to give to type-2 diabetic (and GI) patients a preload along with their usual diabetic medication. 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. Furthermore, most bariatric surgery studies include only late postoperative evaluations of glucose control, such as those made after 7 days or more.

The main hypothesis of this study is that pre-operative carbohydrate loading compared to fasting will optimize the overall pattern of postoperative glucose profile evidenced by Continuous Glucose Monitoring (CGM) with a greater impact in the first few days after surgery on lowering mean glycaemia and glycemic variability in patients with glucose intolerance.

The primary aim is to evaluate the mean of all blood glucose measures of CGM over 24-h period after surgery in patients receiving pre-operative carbohydrate loading in comparison with standard 6h fasting. The mean of all glucose measures over 24- h of CGM (around 288) reflects overall glucose control including fasting and postprandial state. It have been chose to study this early period to minimize any confounding effects of weight loss.

Being tested
carbohydrate supplement (Preload™), 6 hours of preoperative fasting
Medical subject headings
Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 6 hours of preoperative fastingProcedure or surgery

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

Study groups in NCT04343040
Study groupRoleWhat they receive
perioperative glucose intakeExperimentalglucose intolerant patients with perioperative glucose (carbohydrate supplement (Preload™) intake before Gastric By-Pass or Sleeve Gastrectomy.
Receives: Dietary Supplement: carbohydrate supplement (Preload™)
6 hours of preoperative fastingSham comparatorglucose intolerant patients receiving 6 hours of preoperative fasting before Gastric By-Pass or Sleeve Gastrectomy.
Receives: Procedure: 6 hours of preoperative fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 1 after surgery

Secondary outcomes (12)
  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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

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

  7. 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

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

  8. Length of hospital stays after surgery

    regarding the initial bariatric procedure

    Measured: at 1 month after surgery

  9. Rate of early surgical perioperative complications

    within the 30 days after surgery

    Measured: at 1 month after surgery

  10. Rate of patients needing antibiotic therapy

    within the 30 days after surgery

    Measured: at 1 month after surgery

  11. Rate of patients needing reoperation

    within the 30 days after surgery

    Measured: at 1 month after surgery

  12. 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

    Measured: at 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start1 Sep 2022
  3. Primary completion1 Dec 2024
  4. Study completion1 Dec 2024

Why it stopped: Sponsor décision, COVID

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04343040
Sponsor's protocol ID
2017_34
Other IDs
2017-A03320-53
Acronym
PERISURG-CGM
Status last verified
May 2026
First submitted
6 Apr 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing carbohydrate supplement (Preload™) and 6 hours of preoperative fasting in people with Hyperglycaemia (Diabetic) and Bariatric Surgery Candidate, run by University Hospital, Lille.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 1 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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