Diabetes Remission and Hypoabsorptive Bariatric Surgery (DIABAR-3)

• ClinicalTrials.gov Identifier: NCT06043245
• Recruitment Status: Enrolling by invitation
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Hospital Universitari de Bellvitge
• Collaborator: Instituto de Salud Carlos III
• Information provided by (Responsible Party): Nuria Vilarrasa, Hospital Universitari de Bellvitge

Tracking Information

• First Submitted Date: June 11, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: June 21, 2023
• Estimated Primary Completion Date: September 30, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2023)

Type 2 Diabetes (T2D) remission. [ 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 12, 2023)

• Weight loss [ Time Frame: 12 months ]
  Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups
• Entero-endocrine hormone GLP-1 [ 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
• Entero-endocrine hormone PYY [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
  Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups
• Bile salts [ 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
• Intestinal microbiome [ 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
• Epicardial fat [ Time Frame: 12 months ]
  Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diabetes Remission and Hypoabsorptive Bariatric Surgery
• 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
• 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.

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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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).

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Severe Obesity
• Diabetes Mellitus, Type 2
• Bariatric Surgery Candidate

Intervention

• Procedure: Duodenal Switch
  Classic Duodenal Switch
• Procedure: SADI-S
  SADI-S with a 300cm common channel
  Other Name: Single- Anastomosis Duodenal Switch
• Procedure: Minigastric Bypass
  Classic minigastric bypass
  Other Name: Single anastomosis or Omega loop gastric bypass

Study Arms

• 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.
  Intervention: Procedure: 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.
  Intervention: Procedure: SADI-S
• 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.
  Intervention: Procedure: Minigastric Bypass

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 12, 2023): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2027
• Estimated Primary Completion Date: September 30, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT06043245
• Other Study ID Numbers: PR015/23
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Nuria Vilarrasa, Hospital Universitari de Bellvitge
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Universitari de Bellvitge
• Original Study Sponsor: Same as current
• Collaborators: Instituto de Salud Carlos III

Investigators

• Principal Investigator: Nuria Vilarrasa García, PhD, MD; Medical doctor at Hospital Universitari de Bellvitge

• PRS Account: Hospital Universitari de Bellvitge
• Verification Date: September 2023