Circulating Muscle-specific microRNAs and Renal, Nutritional and Inflammatory Biomarkers of Skeletal Muscle Loss During the First 18 Months After Laparoscopic Sleeve Gastrectomy

NCT07806513 | Completed DMC

• 1 other identifier: muscle-specific biomarkers
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic and bariatric surgery produces substantial and durable weight loss, but a considerable proportion of that loss is not adipose tissue. Pooled estimates indicate approximately 8 kg of fat-free mass and 3 kg of skeletal muscle mass are lost within twelve months, with more than half occurring in the first three months. No validated circulating biomarker of skeletal muscle loss exists for this population, and body composition can currently be assessed only intermittently. Muscle-specific microRNAs (myomiRs) are mechanistically plausible candidates but have never been measured in patients undergoing metabolic and bariatric surgery. This study will characterise the trajectory of skeletal muscle loss over eighteen months after laparoscopic sleeve gastrectomy and evaluate, as exploratory analyses, whether circulating myomiRs and routinely accessible renal, nutritional and inflammatory measures track that trajectory.

Conditions

Skeletal Muscle; Bariatric Surgery

Keywords

bariatric surgery; sleeve gastrectomy; sarcopenia; body composition; microRNA; biomarkers

Outcome Measures

Primary Outcomes (1)

• change in skeletal muscle mass

  change in skeletal muscle mass (kg) measured by multifrequency bioelectrical impedance analysis from baseline to eighteen months, using a single device that does not change during the study. Measurement conditions follow ESPEN guidance: overnight fast, no alcohol for 48 hours, no vigorous exercise for 24 hours, bladder voided, consistent time of day and posture. Prediction equations for bioimpedance are validated for a body mass index of 16-34 kg/m² without abnormal hydration, and the present cohort lies above this range while undergoing rapid fluid shifts.

  baseline, 3, 6, 12, 18 months

Secondary Outcomes (3)

• sarcopenia and sarcopenic obesity

  baseline, 3, 6, 12, 18 months

• quantify change in muscle function

  baseline, 3, 6, 12, 18 months

• renal glomerular filtration rate

  baseline, 3, 6, 12, 18 months

Study Arms (1)

primary laparoscopic sleeve gastrectomy

Sleeve gastrectomy: The operation is standard care, not a study intervention, but is standardised and documented because technical variation would otherwise contaminate the biomarker trajectory. Greater curvature devascularisation commences 4-6 cm proximal to the pylorus and extends to the angle of His with complete fundal mobilisation; gastric transection is performed over a 36-40 Fr calibration bougie; staple-line reinforcement policy, operative time, blood loss, resected specimen weight, conversion and length of stay are recorded for every case, and the operating surgeon is entered as a random effect in sensitivity analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort is deliberately restricted to a single procedure to remove procedure type as a source of heterogeneity in a first-in-population biomarker study, and because sleeve gastrectomy is the predominant operation at the participating center. Participants are assessed before surgery (within one week) and at 3, 6, 12 and 18 months. This schedule captures the front-loaded catabolic window and the plateau established by twelve months. At every visit, participants undergo anthropometry, bioimpedance body composition, muscle function testing, dietary and physical-activity assessment, fasting venepuncture, and recording of medication exposure, tolerance and adverse events.

You may qualify if:

• Consecutive adults (≥18 years)
• scheduled for primary laparoscopic sleeve gastrectomy
• meeting current ASMBS/IFSO indications for metabolic and bariatric surgery

You may not qualify if:

• revisional or secondary bariatric procedure
• chronic kidney disease stage 3 or worse
• dialysis or transplantation
• chronic liver disease with synthetic dysfunction
• active or recently treated malignancy
• known neuromuscular or myopathic disease
• systemic corticosteroid or anabolic agent exposure within three months
• cardiac pacemaker or implantable defibrillator
• pregnancy or lactation
• clinical evidence of abnormal hydration at baseline
• inability to perform handgrip or chair-stand testing

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, 21531, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling follows minimum pre-analytical reporting requirements for circulating cell-free microRNA studies, all items of which will be reported. Fasting morning serum is collected at a consistent time of day, with no strenuous exercise for 48 hours beforehand - a mandatory restriction, since circulating miR-1, miR-133a and miR-206 rise acutely after exercise and plasma miR-133a shifts transiently after resistance exercise. Tourniquet time is minimised, samples are clotted for 30 minutes, centrifuged, aliquoted within two hours into separate fractions for chemistry, immunoassay and microRNA, and stored at -80 °C with freeze-thaw limited to one cycle.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: January 17, 2025
• Primary Completion: July 17, 2026
• Study Completion: August 8, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)