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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duodenal switch | Active Comparator | 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. |
|
| SADI-S | Active Comparator | 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. |
|
| Minigastric bypass | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duodenal Switch | Procedure | Classic Duodenal Switch |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuria Vilarrasa GarcÃa, PhD, MD | Medical doctor at Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32240495 | Background | Finno P, Osorio J, Garcia-Ruiz-de-Gordejuela A, Casajoana A, Sorribas M, Admella V, Serrano M, Marchesini JB, Ramos AC, Pujol-Gebelli J. Single Versus Double-Anastomosis Duodenal Switch: Single-Site Comparative Cohort Study in 440 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3309-3316. doi: 10.1007/s11695-020-04566-5. | |
| 36282430 |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Three parallel groups (patients with severe obesity and Type 2 Diabetes) assigned 1:1:1 to undergo duodenal switch (DS), Single anastomosis duodeno-ileal (SADI-S) or Minigastric bypass (MGB).
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| SADI-S |
| Procedure |
SADI-S with a 300cm common channel |
|
|
| Minigastric Bypass | Procedure | Classic minigastric bypass |
|
|
| 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 | 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 | 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 | 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 | 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 | 12 months |
| Epicardial fat | Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups | 12 months |
| Gebelli JP, Lazzara C, de Gordejuela AGR, Nora M, Pereira AM, Sanchez-Pernaute A, Osorio J, Sobrino L, Garcia AJT. Duodenal Switch vs. Single-Anastomosis Duodenal Switch (SADI-S) for the Treatment of Grade IV Obesity: 5-Year Outcomes of a Multicenter Prospective Cohort Comparative Study. Obes Surg. 2022 Dec;32(12):3839-3846. doi: 10.1007/s11695-022-06317-0. Epub 2022 Oct 25. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |