Effect of Gabapentin on Kidney Function Following Laparoscopic Sleeve Gastrectomy(LSG)

Phase 1

Active, not recruiting

• Conditions: Acute Kidney Injury; Bariatric Surgery Candidate; Gabapentin
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT06254183
• Lead Sponsor: Tanta University

Brief Summary

Assessment of the effect of gabapentin as an analgesic replacement on the Kidney function following Laparoscopic sleeve gastrectomy for Morbid Obese Patients by measuring two biomarkers: NGAL (Neutrophil gelatinase-associated lipocalin)and DKK3 (Dickkopf-3)

Detailed Description

Obesity should be viewed as the number one preventable risk factor for kidney disease because obesity mediates the majority of diabetes and hypertension, the 2 major causes of end-stage kidney disease (ESKD). Morbidly obese adults have a 6-fold higher risk of diabetes compared with their lean peers.

Laparoscopic sleeve gastrectomy (LSG) has been approved since 2010, by both the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS) as an operation for the treatment of obesity and other obesity-related diseases.

Acute kidney injury (AKI) is one of the most common postoperative complications. It is a serious morbidity occurring during hospitalizations, and it is associated with prolonged hospital stay, high risk of in-hospital mortality, increased hospital costs, and decreased survival for up to 15 years after surgery. In addition, AKI increases the risk of incident and progressive chronic kidney disease and is associated with reduced long-term survival.

Non-steroidal anti-inflammatory drugs (NSAIDs) represent one of the most common classes of medications used postoperatively. It is estimated that 1-5% of NSAIDs users may develop renal adverse effects, both AKI and CKD.

Gabapentin, an anticonvulsant widely used for the treatment of various neuropathic pain syndromes, has recently been investigated as an analgesic agent in the perioperative setting. Although it is not an analgesic itself, early experience suggests this medication can improve pain and reduce opioid requirements.

A new animal study shows that gabapentin demonstrated reno-protective properties against either acute or chronic kidney injury, primarily attributed to its antioxidant properties. Further clinical studies are required to validate and standardize therapeutic doses of gabapentin under investigation in patients susceptible or at risk of developing kidney dysfunction.

In this study, Neutrophil gelatinase-associated lipocalin (NGAL) and Dickkopf-3 (DKK3) will be biomarkers to assess kidney function. NGAL appears to be a promising marker for early detection of AKI and is likely to be adapted for wide-scale clinical use in patient management as a point-of-care test.

Measurement of DKK3 in urine represents a novel tool for the identification of patients at high risk for AKI regardless of the cause of kidney injury.

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Study Start: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Morbid obese patients with normal kidney function, undergoing Laparoscopic sleeve gastrectomy surgery.
• Both sexes.
• Age ≥ 18 years

Exclusion Criteria

• • Patients have advanced cancer on active treatment and end-stage renal, hepatic, and cardiopulmonary disease.

  • Patients with untreated schizophrenia, cognitive impairment and using psychiatric medications.
  • Patients with active substance abuse.
  • Patients on chronic dosage of Gabapentin or allergic to it.
  • Pregnant women or women on breastfeeding.
  • Patients on medications that could interfere with assessed parameters will be excluded.

The ethical approval of the study will be obtained from by Medical research Ethics Committee of Tanta and Mansoura Universities and all participants will give their written consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	30 patients will represent the treatment group and will receive a single oral dose of Placebo 1 hr before the surgery. Blood and urine samples will be collected before the surgery, then 24 hrs postoperatively.
Gabapentin	Gabapentin	30 patients will represent the treatment group and will receive a single oral dose of Gabapentin 1200 mg 1 hr before the surgery. Blood and urine samples will be collected before the surgery, then 24 hrs postoperatively.

Primary Outcome Measures

Name	Time	Method
Level of Neutrophil gelatinase-associated lipocalin (NGAL)	up to 6 months postoperative	Neutrophil gelatinase-associated lipocalin in Serum using ELISA Kits
Level of Dickkopf-3 (DKK3)	up to 6 months postoperative	Dickkopf-3 in both serum and urine using ELISA kits

Secondary Outcome Measures

Name	Time	Method
Concentration of calcium in serum	up to 6 months postoperative
Kidney function test	up to 6 months postoperative	Blood urea nitrogen
level of Serum creatinine	up to 6 months postoperative
lipid profile (Triglycerides, LDL, HDL)	up to 6 months postoperative

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt