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Examining the effects of Pre surgery nutrition on blood sugar control in patients undergoing laparoscopic gall bladder removal surgery

The Impact of Preoperative Branched Chain Amino Acid Overloading on Insulin Resistance compared to Carbohydrate Overloading and Conventional Fasting in patients undergoing Laparoscopic Cholecystectomy An Open Labelled Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080208
Enrollment
96
Registered
2025-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Preoperative branched chain amino acid overloading: Patients in this group will be given 2 sachets of BCAA (13 mg of BCAA with each sachet containing L-Isoleucine 1.2 gm, L-Leucine 2.3

Sponsors

Dr Baddala Santhosh Reddy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients aged 18 years and older 2.Patients scheduled for elective laparoscopic cholecystectomy 3.BMI within 18.5 29.9 kg/m2 4.ASA PS Classification I or II 5.Willingness to comply with study protocols, including preoperative fasting & BCAA and carbohydrate administration 6.Patients who provide informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1.Patients with pre-existing metabolic disorders like Diabetes, Obesity or any systemic illness that affects Glucose metabolism 2.Previous history of surgery on the oesophagus or stomach 3.Patients with symptoms related to severe GERD or Hiatal hernia 4.Patients with abnormal fasting blood glucose (more than 110 mg/dl)or insulin levels(more than 24.9 U/ml) prior to surgery 5.Chronic Liver Disease /Chronic Kidney Disease /Chronic Endocrine disorders that may affect glucose or amino acid metabolism 6.Pregnant or Breast-Feeding women 7.Use of Insulin/OHA/Medications affecting glucose metabolism within recent period 8.Use of Protein/Amino acid supplements within recent period 9.Conversion to open surgery and bail out procedure will be excluded 10.Patients with cognitive impairment or inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
To study the effect of Pre-operative Branched Chain Amino Acid Overloading on Post-operative Insulin Resistance and Post-Operative Hyperglycaemia in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint will be the successful demonstration of effect of BCAA preloading compared to carbohydrate overloading and conventional overnight fasting on Post-operative Insulin Resistance and post-operative hyperglycaemiaTimepoint: Primary Outcomes will be assessed 12-15 hours before surgery, 1 hour before induction of anesthesia on day of surgery and post operatively on 10th Hour after completion of surgery

Secondary

MeasureTime frame
Assess the Incidence of hyperglycaemia related complications such as Post Operative Hunger, Thirst , Anxiety, Fatigue, Post Operative Nausea & Vomiting ,Prolonged Hospital Stay, Post Operative Pain, Surgical Site Infection, Bowel function recoveryTimepoint: All patients will be followed in post operative period on Day 0 Day 1 Day 2 at time of discharge & at 90 days post surgery.

Countries

India

Contacts

Public ContactDr Ravi Gupta

All India Institute of Medical Sciences Gorakhpur

ravikgmc2004@gmail.com9453302264

Outcome results

None listed

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