Diabetes Remission and Hypoabsorptive Bariatric Surgery

NCT06043245 | Enrolling By Invitation DMC

• 1 other identifier: PR015/23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Diabetes remission; hypoabsortive bariatric surgery; Incretin hormones; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Weight loss

  12 months

• Entero-endocrine hormone GLP-1

  12 months

• Entero-endocrine hormone PYY

  12 months

• Entero-endocrine hormone GIP

  12 months

• Entero-endocrine hormone Ghrelin

  12 months

Study Arms (3)

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.

Procedure: Duodenal Switch

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.

Procedure: SADI-S

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.

Procedure: Minigastric Bypass

Interventions

Duodenal Switch PROCEDURE

Classic Duodenal Switch

Duodenal switch

SADI-S PROCEDURE

SADI-S with a 300cm common channel

Also known as: Single- Anastomosis Duodenal Switch

SADI-S

Minigastric Bypass PROCEDURE

Classic minigastric bypass

Also known as: Single anastomosis or Omega loop gastric bypass

Minigastric bypass

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Corticoid use by oral or intravenous route for more than 14 consecutive days in the last three months.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

• 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.

  PMID: 32240495 BACKGROUND

• 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.

  PMID: 36282430 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Interventions

Anastomosis, Surgical

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Nuria Vilarrasa García, PhD, MD

  Medical doctor at Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: September 21, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)