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Completed
NCT07806448
Impact of Asprosin and Neuregulin 4 on Metabolic Parameters, Anthropometric Indices and Body Composition After Laparoscopic Sleeve Gastrectomy
Conditions: Bariatric Sleeve Gastrectomy
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Enrollment: 160
Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Location: The surgical department of Medical Research Institute Hospital, Alexandria University Alexandria
Summary
Asprosin and neuregulin 4 (NRG4) sit on opposing arms of adipose endocrine physiology. Asprosin is a fasting-induced, white adipose-derived glucogenic and orexigenic hormone that rises with adiposity and insulin resistance. NRG4 is a brown and beige adipose-derived, anti-lipogenic and hepatoprotective factor that falls with adiposity. Both have been examined separately after metabolic and bariatric surgery, but never in the same cohort, and existing surgical data cannot separate a weight-loss-dependent effect from an effect of the operation itself.
Objectives: To quantify the change in fasting serum asprosin and NRG4 over twelve months after laparoscopic sleeve gastrectomy (LSG); to determine whether those changes are associated with metabolic improvement independently of weight loss; and to characterise their relationship with anthropometric indices and body composition.
Eligibility Criteria
Inclusion Criteria:
* body mass index of at least 35 kg/m² regardless of the presence
* absence or severity of obesity-related comorbidities
* should be considered at 30-34.9 kg/m² in the presence of metabolic disease
Exclusion Criteria:
* revisional or emergency surgery
* type 1 diabetes or insulin-treated type 2 diabetes
* use within three months of a GLP-1 receptor agonist
* dual GIP/GLP-1 receptor agonist
* SGLT2 inhibitor or thiazolidinedione
* systemic corticosteroid or immunosuppressive therapy
* chronic liver disease of non-metabolic aetiology or cirrhosis
* alcohol intake above 20 g/day in women or 30 g/day in men
* estimated glomerular filtration rate below 60 mL/min/1.73 m²
* FBN1-related connective tissue disorder
* active or recent malignancy
* untreated thyroid
* adrenal or gonadal disorder
* pregnancy or lactation
* any device precluding bioelectrical impedance analysis
* high-sensitivity C-reactive protein above 10 mg/L at baseline
Source: ClinicalTrials.gov (NCT07806448). StuddyBuddy aggregates publicly available trial information.