NCT06043245Enrolling by invitation
Diabetes Remission and Hypoabsorptive Bariatric Surgery
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 11 Jun 2023
- Start date
- 21 Jun 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06043245
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 21 Jun 2023 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positivity for GAD auto-antibodies
- Previous bariatric surgery
Other illness
- Type 1 diabetes
- Secondary forms of diabetes
- Severe liver disease
Other
- Acute metabolic complications in the last 6 months
- Renal dysfunction
- Patients under anticoagulant treatment
- 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.
Who the study is looking for
- BMI\>45 kg/m2
- T2D on treatment with hypoglycemic agents alone, insulin or both.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.