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Evaluation of the efficacy and safety of preoperative oral carbohydrates in type 2 diabetes patients following extremities fracture surgery

Evaluation of the efficacy and safety of preoperative oral carbohydrates in type 2 diabetes patients following extremities fracture surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086212
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

NO-OCH group:Patients were given 400 ml of flavored water at 2 hours before the initiation of anesthesia
OCH group:Patients were given 400 ml of oral carbohydrate solution at 2 hours before the initiation of anesthesia

Sponsors

the Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria will be: (1) Male or female subject previously diagnosed as T2DM in accordance with the criteria set forth by World Health Organization (WHO) ; (2) Age between 18 to 65 years; (3) American Society of Anesthesiologists (ASA) grade II - III, surgery for upper extremity fractures (humerus, ulna and radius fractures) and lower extremity fractures (femoral shaft, patella, tibia, fibula, knee and ankle fractures); (4) Hemoglobin A1c (HbA1c) = 70 mmol/mol; (5) Body mass index (BMI) 18 to 30 kg/m2; (6) agree to participate in the study and provides written informed consent.

Exclusion criteria

Exclusion criteria: (1) Weight loss greater than 10 per cent during the previous 6 months; (2) Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis); (3) Hepatic insufficiency (Child-Pugh class = B); (4) Gastro-oesophageal reflux disease; (5) Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate; (6) Alnutrition or severe anemia disease: ALB < 35g/L, Hb < 90g/L; (7) Electrolyte Imbalance, abnormal blood coagulation, pregnancy, sleep disorders; (8) history of drug allergy; (9) Participation in another trial with an investigational drug within 30 days before informed consent; (10) Treatment with systemic steroids, antipsychotic drugs or cancer therapeutics such as glucocorticoids, chemotherapy, hormonal therapies and targeted drugs which may induce insulin resistance.

Design outcomes

Primary

MeasureTime frame
HOMA-IR;

Secondary

MeasureTime frame
thirst, hunger, and nausea;Anxiety ;HOMA-IR at other time point;Postoperative comfort outcomes;Quality of sleep;nausea and vomiting after surgery;postoperative fever;the indwelling time of the drainage tube;the first oral feeding time;the first bowel sounds time; total duration of postoperative hospitalization;

Countries

China

Contacts

Public Contactzhaoyang xiao

The Second Affiliated Hospital of Dalian Medical University

liliya1014@163.com+86 177 0987 5203

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026