Severe ObesityDIABAR-3NCT06043245

Diabetes Remission and Hypoabsorptive Bariatric Surgery

A study testing Duodenal Switch, SADI-S and Minigastric Bypass in people with Severe Obesity and Diabetes Mellitus, Type 2, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Severe Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate
What is being tested?: Duodenal Switch, SADI-S and Minigastric Bypass
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteSpain
Study dates: 21 Jun 2023to 30 Sep 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Severe Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate
Being tested: Duodenal Switch, SADI-S, Minigastric Bypass
Keywords: Diabetes remission, hypoabsortive bariatric surgery, Incretin hormones, Gut microbiota
Medical subject headings: Obesity, Morbid, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duodenal SwitchProcedure or surgery
Classic Duodenal Switch
SADI-SProcedure or surgery
Also called Single- Anastomosis Duodenal Switch
SADI-S with a 300cm common channel
Minigastric BypassProcedure or surgery
Also called Single anastomosis or Omega loop gastric bypass
Classic minigastric bypass

Study groups in NCT06043245
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Procedure: Minigastric Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202330 Sep 2027

First posted21 Sep 2023
Study start21 Jun 2023
Primary completion30 Sep 2026 (estimated)
Study completion30 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Severe ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06043245
Sponsor's protocol ID: PR015/23
Acronym: DIABAR-3
Status last verified: Sep 2023
First submitted: 11 Jun 2023
Last updated: 21 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 32240495
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.
PubMed 36282430

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruitingObservational study
Prospective Study of an Explainable AI Tool to Support Biliopancreatic Limb Selection in One-Anastomosis Gastric Bypass
Obesity, Severe Obesity
RecruitingObservational study
Early Discharge With Hospital-at-Home After Bariatric Surgery and Economic Evaluation.
Severe Obesity, Morbid Obesity Requiring Bariatric Surgery
Active, not recruitingPhase 2/3
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial
Severe Obesity, Obesity
Not yet recruiting
Comparison of Day Hospitalization Versus Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity
Severe Adolescent Obesity, Adolescent Obesity

All Severe Obesity trials