Diabetes Mellitus, Type 2 Clinical Trial
— DIABAR-3Official 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
Verified date | September 2023 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari de Bellvitge | L'Hospitalet De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge | Instituto de Salud Carlos III |
Spain,
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
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 |
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