Clinical trial NCT06043245: Diabetes Remission and Hypoabsorptive Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Severe Obesity
Diabetes Mellitus, Type 2
Bariatric Surgery Candidate
Keywords: Diabetes remission
hypoabsortive bariatric surgery
Incretin hormones
Gut microbiota
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2023-09-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Type 2 Diabetes (T2D) remission.
timeFrame: 12 months
Secondary outcomes:
measure: Weight loss
timeFrame: 12 months
measure: Entero-endocrine hormone GLP-1
timeFrame: 12 months
measure: Entero-endocrine hormone PYY
timeFrame: 12 months
measure: Entero-endocrine hormone GIP
timeFrame: 12 months
measure: Entero-endocrine hormone Ghrelin
timeFrame: 12 months
measure: Bile salts
timeFrame: 12 months
measure: Intestinal microbiome
timeFrame: 12 months
measure: Epicardial fat
timeFrame: 12 months
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Medical doctor at Hospital Universitari de Bellvitge
name: Nuria Vilarrasa García, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 Prospective Cohort Comparative Study. Obes Surg. 2022 Dec;32(12):3839-3846. doi: 10.1007/s11695-022-06317-0. Epub 2022 Oct 25.