Clinical trial

Different Limb Lengths in Gastric Bypass Surgery (SLIM) - Part 3: Metabolism and Inflammation

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05471037

Active, not recruitingNot applicableInterventional

What this study is about

Investigation of underlying metabolic mechanisms and impact on the two surgical procedures on inflammatory factors.

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 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Morbid

Full registry criteria

Inclusion Criteria: * 2 x 25 patients with morbid obestiy (BMI of 35 kg/m2 or higher) who comply with the regulatory rules for bariatric surgery in Switzerland (SMOB guidelines) and participate in the SLIM Trial * 15 healthy lean controls Exclusion Criteria: * general contraindications to kind of surgery * known or suspected non-compliance * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant * participation in another interventional study * BMI \> 60 kg/m2 * height \< 145 cm * CL length of \< 180 cm as measured intraoperatively * ASA physical status classification \> III * inflammatory bowel disease * diabetes * intake of corticosteroids, anti-inflammatory/ immunosuppressive drugs potentially altering immune cells * clinical signs of current infection * known anemia (e.g. hemoglobin \< 110g/L for males, \< 100g/L for females) * known neutropenia (e.g. leucocyte count \< 1.5 x 10\^9/L or ANC \< 0.5 x 10\^9/L) * known immunodeficiency, e.g. HIV * known vasculitis, collagenosis * known adrenal insufficiency and/or substitution with glucocorticoids * risky daily alcohol consumption (\> 24g/d for males, \> 12g/d for females) * drug abuse * known liver cirrhosis Child B or C * known uncontrolled congestive heart failure * known uncontrolled malignant disease * currently pregnant or breastfeeding

Treatments and study arms

Long Biliopancreatic Limb LRYGB

Procedure

LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.

Short Biliopancreatic Limb LRYGB

Procedure

Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Primary outcomes

Change in glucose tolerancepre-OP and 6-8 months post-OP

Change in glucose tolerance as measured by plasma glucose concentrations at 120 minutes after ingestion of a standardized liquid test meal, pre-OP and 6-8 months post-OP.

Study locations

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

St Clara Research Ltd, St Claraspital Basel🇨🇭 Basel, Switzerland