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Clinical Trials in Spain / NCT06043245
Enrolling by invitation Not applicable

Diabetes Remission and Hypoabsorptive Bariatric Surgery

NCT06043245 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari de Bellvitge
Phase
Not applicable
Started
2023-06-21
Last updated
2023-09-21

Condition(s) studied

Severe ObesityDiabetes Mellitus, Type 2Bariatric Surgery Candidate

Investigational drug(s) / intervention(s)

Duodenal SwitchSADI-SMinigastric Bypass

Duodenal Switch: Classic Duodenal Switch

SADI-S: SADI-S with a 300cm common channel

Minigastric Bypass: Classic minigastric bypass

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona

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NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06043245 on ClinicalTrials.gov ↗ ← All trials in Spain