Diabetes Remission and Hypoabsorptive Bariatric Surgery

NCT ID: NCT06043245

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-21
• Study Completion Date: 2027-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Duodenal Switch

Intervention Type: PROCEDURE

Classic Duodenal Switch

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.

Group Type: ACTIVE_COMPARATOR

SADI-S

Intervention Type: PROCEDURE

SADI-S with a 300cm common channel

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.

Group Type: ACTIVE_COMPARATOR

Minigastric Bypass

Intervention Type: PROCEDURE

Classic minigastric bypass

Interventions

Duodenal Switch

Classic Duodenal Switch

Intervention Type: PROCEDURE

SADI-S

SADI-S with a 300cm common channel

Intervention Type: PROCEDURE

Minigastric Bypass

Classic minigastric bypass

Intervention Type: PROCEDURE

Other Intervention Names

Single- Anastomosis Duodenal Switch; Single anastomosis or Omega loop gastric bypass

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Nuria Vilarrasa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuria Vilarrasa García, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Medical doctor at Hospital Universitari de Bellvitge

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 32240495 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36282430 (View on PubMed)

Other Identifiers

PR015/23

Identifier Type: -

Identifier Source: org_study_id