An interventional study of Long BPL LRYGB and Short BPL LRYGB in Obesity, Morbid, Diabetes Mellitus, Type 2 and Hypertension, sponsored by Clarunis - Universitäres Bauchzentrum Basel. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Clarunis - Universitäres Bauchzentrum Basel · Not applicable, Interventional, and Treatment
Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 800 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Clarunis - Universitäres Bauchzentrum Basel is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
Procedure: Long BPL LRYGB
Standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Procedure: Short BPL LRYGB
LRYGB with an 180 cm BPL and an AL of 80 cm.
Also known as: LBPL LRYGB
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Also known as: SBPL LRYGB
Primary endpoint
Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).
Time frame: From baseline to 5 years after surgery.
Secondary endpoints
Percent excess body mass index loss (%EBMIL), remission of comorbidities, complication rate/safety, and quality of life 1, 3, and 5 years after long and short BPL RYGB.
Time frame: From baseline to 5 years after surgery.
Plan to share: No
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Clarunis - Universitäres Bauchzentrum Basel