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Diabetes Remission and Hypoabsorptive Bariatric Surgery (DIABAR-3)

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

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : June 21, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Single anastomosis or Omega loop gastric bypass


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 12 months ]
    Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043245


Locations
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Spain
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Nuria Vilarrasa García, PhD, MD Medical doctor at Hospital Universitari de Bellvitge
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Nuria Vilarrasa, Principal Investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT06043245    
Other Study ID Numbers: PR015/23
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuria Vilarrasa, Hospital Universitari de Bellvitge:
Diabetes remission
hypoabsortive bariatric surgery
Incretin hormones
Gut microbiota
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight