PRECI-Surg: Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Standard Roux-en-Y
|
Procedure: Standard Roux-en-Y gastric bypass
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).
|
| Active Comparator: Long alimentary limb Roux-en-Y
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Procedure: Long alimentary limb Roux-en-Y gastric bypass
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
|
Outcome Measures
Primary Outcome Measures
- Rate of type 2 diabetes remission [at 12 months after surgery]
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
Secondary Outcome Measures
- Absolute weight loss (aWL in kg) [at 1, 3, 6 and 12 months after surgery]
- Excess Weight Loss percentage (EWL%) [at 1, 3, 6 and 12 months after surgery]
- Excess BMI Loss percentage (EBL%) [at 1, 3, 6 and 12 months after surgery]
- Medical and surgical complication rates [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)
- Type and severity of early and late complications for each procedure [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
- Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire [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)
- Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery. [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.
- Change in glucose homeostasis [Before surgery and at 3, 6 and 12 months after surgery]
glucose (mg/dl)
- Change in HbA1c [Before surgery and at 3, 6 and 12 months after surgery]
Changes in HbA1c(%) were assessed before and after surgery
- Change in fasting glycemia [Before surgery and at 3, 6 and 12 months after surgery]
Changes in fasting blood glucose levels (mmol/L)
- changes in fasting insulinemia [Before surgery and at 3, 6 and 12 months after surgery]
Changes in fasting insulinemia in microunits/mL
- change in fasting c-peptide [Before surgery and at 3, 6 and 12 months after surgery]
Changes in C-peptide(ng/ml) were assessed before and after the intervention.
- Number of antidiabetic treatments [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
- Changes in blood lipids profile [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
- change in vitamins status assessment [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
- change in prealbumin levels [Before surgery and at 1, 3, 6 and 12 months after surgery]
Lower levels of prealbumin are associated with malnutrition.
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI ≥ 35 kg/m2
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All patient with type 2 diabetes
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Patients who were candidates for obesity surgery in accordance with French recommendation
Exclusion Criteria:
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Severe cognitive or mental disorders
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patient who have already undergone obesity surgery
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Severe and non-stabilised eating disorders
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The likely inability of the patient to participate in lifelong medical follow-up
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Alcohol or psychoactive substances dependence
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The absence of identified prior medical management of obesity
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Diseases that are life-threatening in the short and medium term;
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Contraindications to general anaesthesia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Amiens Picardie | Amiens | France | ||
| 2 | Ch Boulogne-Sur-Me | Boulogne Sur Mer | France | 62321 | |
| 3 | Hop Claude Huriez Chu Lille | Lille | France | 59037 | |
| 4 | Ch de Valenciennes | Valenciennes | France |
Sponsors and Collaborators
- University Hospital, Lille
- Ministry of Health, France
Investigators
- Principal Investigator: Grégory BAUD, MD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017_02
- 2017-A01761-52
- PHRCI-16-090