Diabetes Remission and Hypoabsorptive Bariatric Surgery
Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Sep 12, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Patients fulfilling inclusion criteria will be randomly assigned 1:1:1 to undergo DS, SADI-S or MGB. Allocation of patients will be assigned by simple randomization with stratification according to baseline levels of HbA1c (greater or lower/ equal to 7 %).
Protocol 0. Screening visit: All participants will be required to sign the informed consent, according to the regulations of the Committee of the center. Clinical, analytical, and general physical examination data will be collected and it will be checked the fulfillment of inclusion criteria.
1. Visit 1 (1 week after screening visit): A...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • BMI\>45 kg/m2
- • T2D on treatment with hypoglycemic agents alone, insulin or both.
- Exclusion Criteria:
- • Type 1 diabetes
- • Positivity for GAD auto-antibodies
- • Secondary forms of diabetes
- • Acute metabolic complications in the last 6 months
- • Severe liver disease
- • Renal dysfunction
- • Patients under anticoagulant treatment
- • Previous bariatric surgery
- • Congenital or acquired abnormalities of the digestive tract
- • Pregnancy
- • Nursing or desired pregnancy in the 12 months following inclusion
- • Corticoid use by oral or intravenous route for more than 14 consecutive days in the last three months.
About Hospital Universitari De Bellvitge
Hospital Universitari de Bellvitge is a leading academic medical center located in L'Hospitalet de Llobregat, Spain, affiliated with the University of Barcelona. Renowned for its commitment to advanced patient care, innovative research, and education, the hospital plays a pivotal role in the development and execution of clinical trials across various therapeutic areas. With a multidisciplinary team of healthcare professionals and researchers, Hospital Universitari de Bellvitge strives to enhance medical knowledge and improve treatment outcomes through rigorous scientific inquiry and collaboration. Its state-of-the-art facilities and comprehensive patient care services make it an ideal environment for conducting high-quality clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
L'hospitalet De Llobregat, Barcelona, Spain
Patients applied
Trial Officials
Nuria Vilarrasa García, PhD, MD
Principal Investigator
Medical doctor at Hospital Universitari de Bellvitge
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported