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.

Diabetes Remission and Hypoabsorptive Bariatric Surgery

Severe Obesity

Diabetes Mellitus, Type 2

Bariatric Surgery Candidate

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): Anthropometrical data will be collected, and
           general biochemical analytics including HbA1c, lipid profile and nutritional parameters
           and vitamins will be performed. Also a standard meal test (SMT) will be done with
           determination of GLP-1, PYY, GIP , and ghrelin, insulin, glucose and succinate
           concentrations before and during the SMT. A complete body composition study including
           DEXA, BIA and cardiac resonance to determine epicardia fat will be performed. Feces
           samples will be collected to determine gut microbiota. Quality of live questionnaire
           will be provided.

        2. Visit2 (1 month after surgery): Glycaemia diaries will be checked. Anthropometrical,
           general biochemical analysis with determination of HbA1c, lipid profile and nutritional
           parameters and vitamins will be done. SMT will be performed with determination of GLP-1,
           PYY, GIP, ghrelin, insulin, glucose. A determination of bile acids will be done before
           starting the meal test. feces samples will be collected to determine gut microbiota.

        3. Visit 3 (3 months after surgery): Glycaemia diaries will be checked. Anthropometrical,
           general biochemical analysis with determination of HbA1c, lipid profile and nutritional
           parameters and vitamins will be done.

        4. Visit 4 (12 months after surgery): The same determinations of visit 1 will be performed
           12 months after surgery.

Duodenal Switch

SADI-S

Minigastric Bypass

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

Number of participants achieving T2D remission (HbA1c <6.5% without anti-diabetic treatment) in each arm group one year after surgery.

Principal Investigator

Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups

Changes in plasma concentrations of gut hormone GLP-1 from baseline to 12 months after surgery in the three arm groups

Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups

Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups

Changes in plasma concentrations of primary and secondary bile salts from baseline to 12 months after surgery in the three arm groups

Changes in the ratio of Firmicutes and bacteroidetes species from baseline to 12 months after surgery in the three arm groups

Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups

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.

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.

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.

Diabetes Remission and Hypoabsorptive Bariatric Surgery

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status