NCT07830537Toborzás még nem indult
Preoperative Oral Carbohydrate Loading in Patients With Type 2 Diabetes Undergoing Gastrointestinal Surgery
Effects of Preoperative Oral Carbohydrate Loading on Postoperative Insulin Resistance and Glycemic Stability in Patients With Type 2 Diabetes Undergoing Elective Gastrointestinal Surgery: A Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 21.
Rövid összefoglaló (regiszter, angolul)
This study is a single-center randomized controlled trial in adults with type 2 diabetes who are scheduled for elective gastrointestinal surgery. The study aims to find out whether drinking a carbohydrate-containing clear liquid before surgery can reduce early postoperative insulin resistance and improve blood glucose stability without increasing the risk of high or low blood glucose. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups. The first group will receive standard enhanced recovery after surgery (ERAS) fasting and clear-fluid management without a carbohydrate-containing drink. The second group will drink 400 mL of a 12.5% maltodextrin carbohydrate solution, providing about 50 g of carbohydrate, approximately 2 hours before anesthesia. The third group will receive 500 mL of 10% glucose solution intravenously over approximately 2 hours before anesthesia. The intravenous glucose group is included mainly to help explore whether the route of carbohydrate administration affects the metabolic response. All participants will receive standard perioperative care. Blood glucose will be monitored during the perioperative period, including continuous glucose monitoring when available, with point-of-care blood glucose testing used to confirm clinically important high or low glucose readings and to guide treatment when necessary. The primary outcome is insulin resistance on the first day after surgery, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which is calculated from fasting blood glucose and fasting insulin concentrations. Secondary outcomes include perioperative glucose levels and glucose variability, time spent within, above, and below the target glucose range, insulin and C-peptide levels, postoperative nausea and vomiting, patient comfort, postoperative recovery, hospital stay, postoperative complications, and safety events such as hypoglycemia, severe hyperglycemia, reflux, or aspiration. The main comparison of interest is between the oral carbohydrate group and the standard ERAS group. The intravenous glucose group will be analyzed mainly as a mechanistic exploratory group.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 126 (tervezett)
- Első benyújtás
- 2026. szept. 15.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2027. nov. 1.
- Fő szponzor
- The Affiliated Hospital of Qingdao University
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07830537
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 126
- 2026. okt. 1. és az elsődleges befejezés (2027. nov. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- 1. Known or highly suspected diabetic gastroparesis, delayed gastric emptying, gastric outlet obstruction, or upper gastrointestinal obstruction.
- Severe gastroesophageal reflux disease or other conditions considered by the investigator to confer a high risk of aspiration.
- Emergency surgery or other non-elective surgery for which the study intervention cannot be implemented as planned.
- Type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
- Pregnancy or breastfeeding. 6. Recent systemic glucocorticoid therapy. 7. Severe hepatic or renal dysfunction, or active severe infection. 8. Inability to comply with CGM use, cognitive or psychiatric conditions preventing completion of study assessments, or anticipated poor adherence to the study protocol.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Kiket keres a vizsgálat
- 1.Age 18 to 75 years, regardless of sex. 2.Diagnosis of type 2 diabetes mellitus. 3.Glycated hemoglobin (HbA1c) ≤8.0%, with preoperative fasting plasma glucose generally ≤10.0 mmol/L.
- 4.Scheduled to undergo elective gastrointestinal surgery. 5.Able to wear a continuous glucose monitoring (CGM) device for at least 24 hours before surgery and willing to continue monitoring until hospital discharge or the protocol-specified time point.
- 6.Able to understand the study procedures, voluntarily participate in the study, and provide written informed consent.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.