NCT Number: NCT03821636
In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. The mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is diminished by RYGB and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. The aim of the present study is to compare the impact of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in severely obese patients.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Chu Amiens Picardie, Amiens, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 25 % of total length of the intestine (150 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 65 % of total length of the intestine (400 cm).
Long alimentary limb Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 45 % of total length of the intestine (280 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 45 % of total length of the intestine (280 cm
Time frame: at 12 months after surgery
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
Time frame: at 1, 3, 6 and 12 months after surgery
Time frame: at 1, 3, 6 and 12 months after surgery
Time frame: at 1, 3, 6 and 12 months after surgery
Time frame: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia)
Time frame: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification
Time frame: Before surgery and at 12 after surgery
The IWQOL questionnaire to be specifically assess the effects of obesity on health-related quality of life. The five identified scales are Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work.
The final 20-item IWQOL includes two primary domains: Physical (7 items) and Psychosocial (13 items)
Time frame: Before surgery and at 12 after surgery
GIQLI (gastrointestinal quality of life index) questionnaire. 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
Time frame: Before surgery and at 3, 6 and 12 months after surgery
glucose (mg/dl)
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Changes in HbA1c(%) were assessed before and after surgery
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Changes in fasting blood glucose levels (mmol/L)
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Changes in fasting insulinemia in microunits/mL
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Changes in C-peptide(ng/ml) were assessed before and after the intervention.
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Metabolic profile of glucose homeostasis assessment according to antidiabetic treatments, HbA1c level, fasting glycemia, fasting insulinemia fasting c-peptide
Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
Changes in blood lipids profile (LDL, HDL and triglyceride concentrations) according to anitilipidemic treatments
Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
vitamines profil (vitamin B1, B9, B12, and D concentration) before and 12 and 24 months after surgery
Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
Lower levels of prealbumin are associated with malnutrition.
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. A Prospective, Multicentric, Randomized, Controlled Trial.
Acronym: PRECI-Surg
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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