DIABAR-3: Diabetes Remission and Hypoabsorptive Bariatric Surgery

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06043245

Collaborator

Instituto de Salud Carlos III (Other)

Enrollment

Location

Arms

51.3

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Severe Obesity Diabetes Mellitus, Type 2 Bariatric Surgery Candidate	Procedure: Duodenal Switch Procedure: SADI-S Procedure: Minigastric Bypass	N/A

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 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.

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.
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.
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.
Visit 4 (12 months after surgery): The same determinations of visit 1 will be performed 12 months after surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 21, 2023

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Sep 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Duodenal switch 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 Classic Duodenal Switch
Active Comparator: SADI-S 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 SADI-S with a 300cm common channel Other Names: Single- Anastomosis Duodenal Switch
Active Comparator: Minigastric bypass 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 minigastric bypass Other Names: Single anastomosis or Omega loop gastric bypass

Arm

Intervention/Treatment

Active Comparator: Duodenal switch

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

Classic Duodenal Switch

Active Comparator: SADI-S

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

SADI-S with a 300cm common channel

Other Names:

Single- Anastomosis Duodenal Switch

Active Comparator: Minigastric bypass

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 minigastric bypass

Other Names:

Single anastomosis or Omega loop gastric bypass

Outcome Measures

Primary Outcome Measures

Type 2 Diabetes (T2D) remission. [12 months]
Number of participants achieving T2D remission (HbA1c <6.5% without anti-diabetic treatment) in each arm group one year after surgery.

Secondary Outcome Measures

Weight loss [12 months]
Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups
Entero-endocrine hormone GLP-1 [12 months]
Changes in plasma concentrations of gut hormone GLP-1 from baseline to 12 months after surgery in the three arm groups
Entero-endocrine hormone PYY [12 months]
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
Entero-endocrine hormone GIP [12 months]
Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups
Entero-endocrine hormone Ghrelin [12 months]
Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups
Bile salts [12 months]
Changes in plasma concentrations of primary and secondary bile salts from baseline to 12 months after surgery in the three arm groups
Intestinal microbiome [12 months]
Changes in the ratio of Firmicutes and bacteroidetes species from baseline to 12 months after surgery in the three arm groups
Epicardial fat [12 months]
Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI>45 kg/m2
T2D on treatment with hypoglycemic agents alone, insulin or both.

Exclusion Criteria:

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.