Status:
ENROLLING_BY_INVITATION
Diabetes Remission and Hypoabsorptive Bariatric Surgery
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Severe Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Bariatric surgery is the most effective treatment to achieve type 2 Diabetes Mellitus (DM) remission in patients with severe obesity. However, there is little evidence of the effectiveness and pathoph...
Detailed Description
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 ba...
Eligibility Criteria
Inclusion
- BMI\>45 kg/m2
- T2D on treatment with hypoglycemic agents alone, insulin or both.
Exclusion
- 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.
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06043245
Start Date
June 21 2023
End Date
September 30 2027
Last Update
September 21 2023
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907