Diabetes Remission and Hypoabsorptive Bariatric Surgery

Diabetes Mellitus, Type 2 Clinical Trial

— DIABAR-3  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06043245
• Other study ID #: PR015/23
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: September 2023
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Duodenal Switch
Classic Duodenal Switch
• SADI-S
SADI-S with a 300cm common channel
• Minigastric Bypass
Classic minigastric bypass

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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 Pros — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight loss	Percentage of total weight loss from baseline to 12 months after surgery in the three arm groups	12 months
Secondary	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	12 months
Secondary	Entero-endocrine hormone PYY	Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups	12 months
Secondary	Entero-endocrine hormone GIP	Changes in plasma concentrations of gut hormone PYY from baseline to 12 months after surgery in the three arm groups	12 months
Secondary	Entero-endocrine hormone Ghrelin	Changes in plasma concentrations of gut hormone Ghrelin from baseline to 12 months after surgery in the three arm groups	12 months
Secondary	Bile salts	Changes in plasma concentrations of primary and secondary bile salts from baseline to 12 months after surgery in the three arm groups	12 months
Secondary	Intestinal microbiome	Changes in the ratio of Firmicutes and bacteroidetes species from baseline to 12 months after surgery in the three arm groups	12 months
Secondary	Epicardial fat	Changes in epicardial fat from baseline to 12 months after surgery measured in mm2 in the three arm groups	12 months