An interventional study of Duodenal Switch and SADI-S in Severe Obesity, Diabetes Mellitus, Type 2 and Bariatric Surgery Candidate, sponsored by Hospital Universitari de Bellvitge. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 66 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
The restrictive portion of the surgery involves removing approximately 70% of the stomach (along the greater curvature) and most of the duodenum. The malabsorptive portion of the surgery reroutes a lengthy portion of the small intestine, creating two separate pathways and one common channel.The common channel is 200 cm and 100m the alimentary limb.
Procedure: Duodenal Switch
Creation of a sleeve gastrectomy (SG) and a duodenal-ileal anastomosis with preservation of the pylorus, jejunal exclusion and a total common-alimentary limb, originally measuring 200 cm and later standardized to 300 cm to reduce the risk of nutritional deficiencies.
Procedure: SADI-S
Creation of a gastric pouch similar to Sleeve gastrectomy and the small bowel is run to 200 cm distal to Treitz' ligament and then anastomosed antecolic end-to-side to the gastric pouch.
Procedure: Minigastric Bypass
Classic Duodenal Switch
SADI-S with a 300cm common channel
Also known as: Single- Anastomosis Duodenal Switch
Classic minigastric bypass
Also known as: Single anastomosis or Omega loop gastric bypass
Type 2 Diabetes (T2D) remission.
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
Weight loss
Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Entero-endocrine hormone GLP-1
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
Entero-endocrine hormone PYY
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Entero-endocrine hormone GIP
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Entero-endocrine hormone Ghrelin
Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups
Time frame: 12 months
Bile salts
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
Intestinal microbiome
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
Epicardial fat
Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups
Time frame: 12 months
Plan to share: No
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Hospital Universitari de Bellvitge