Type 2 Diabetes
Conditions
Interventions
Control Group:Overnight Fasting
Intervention Group:Preoperative Oral Carbohydrate Solution
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 60 years, scheduled for primary unilateral elective total hip/knee arthroplasty; 2.Diagnosis of Type 2 Diabetes Mellitus (based on WHO criteria); 3.Body Mass Index (BMI) between 18.5 and 30 kg/m²; 4.Ability to take oral medication independently and capable of completing the preoperative Carbohydrate (CHO) loading protocol; 5.American Society of Anesthesiologists (ASA) Physical Status Classification of I to III; 6.Voluntary participation in the study, provision of written informed consent, and willingness to comply with all study-related follow-up procedures;
Exclusion criteria
Exclusion criteria: 1.History of Type 1 Diabetes Mellitus or Diabetic Ketoacidosis; 2.Poorly controlled diabetes, defined as fasting blood glucose > 10 mmol/L and/or glycated hemoglobin (HbA1c) >= 8.0% within the past 3 month; 3.Significant gastrointestinal motility disorders (e.g., gastroparesis, gastric retention) or a confirmed diagnosis of diabetic autonomic neuropathy; 4.Coexisting severe cardiovascular or cerebrovascular diseases, such as New York Heart Association (NYHA) Class III~IV heart failure or a recent history of stroke; 5.Use within the past 3 months of corticosteroids, immunosuppressants, GLP-1 receptor agonists, dopamine agonists, opioids, or any other medications known to significantly delay gastric emptying; 6.Current or recent treatment for any malignancy, and/or significant hepatic or renal impairment (estimated glomerular filtration rate (eGFR) 3 times the upper limit of normal); 7.Cognitive impairment that would preclude cooperation with rehabilitation assessments; 8.Known allergy to any component of the study product;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of time spent within the target glucose range (TIR, 3.9–10.0 mmol/L) during the 0–72 hour postoperative period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery-related outcomes (length of stay metrics, postoperative complications, functional recovery metrics);Gastric Volume Assessment;incidence of postoperative delirium;Parameters measured on the first postoperative day included inflammatory mediators (IL-6, CRP), fasting blood glucose, insulin levels?HOMA-IR;Glucose-related metrics (mean blood glucose, glycemic variability indices, hypoglycemic and hyperglycemic events);Cognitive Function; | — |
Countries
China
Contacts
Public ContactYongmei Shi
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed