Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
NCT Number: NCT06043245
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 pathophysiological mechanisms involved in metabolic improvement after hypoabsortive tecniques such as duodenal switch (DS), single anastomosis duodenal switch (SADI-S) or minigastric bypass (MGB). We have designed a randomized study to compare type 2 diabetes remission after the 3 bariatric procedures in patients with severe obesity (BMI > 45kg/m2) and to study the implication of gastrointestinal hormones, bile acids and gut microbiota in metabolic improvement in each procedure.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Classic Duodenal Switch
SADI-S with a 300cm common channel
Other names: Single- Anastomosis Duodenal Switch
Classic minigastric bypass
Other names: Single anastomosis or Omega loop gastric bypass
Time frame: 12 months
Number of participants achieving T2D remission (HbA1c <6.5% without anti-diabetic treatment) in each arm group one year after surgery.
Time frame: 12 months
Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in plasma concentrations of gut hormone GLP-1 from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in plasma concentrations of primary and secondary bile salts from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in the ratio of Firmicutes and bacteroidetes species from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups
Hospital Universitari de Bellvitge
Other
Prognostic Factors and Predictors of Diabetes Remission in Hypoabsorptive Bariatric Surgery Techniques. Randomized Comparative Study Between Duodenal Switch, Single-Anastomosis Duodenal Switch (SADI-S) and Mini-Gastric Bypass
Acronym: DIABAR-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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