Clinical trial

Diabetes Remission and Hypoabsorptive Bariatric Surgery

Invitation only · Not applicable · 1 countries · Registry ID NCT06043245

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionSevere Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate

Full registry 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.

Treatments and study arms

Duodenal Switch

Procedure

Classic Duodenal Switch

SADI-S

Procedure

SADI-S with a 300cm common channel

Minigastric Bypass

Procedure

Classic minigastric bypass

Primary outcomes

Type 2 Diabetes (T2D) remission.12 months

Number of participants achieving T2D remission (HbA1c \<6.5% without anti-diabetic treatment) in each arm group one year after surgery.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Universitari de Bellvitge🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

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