Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.

Официальное название

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.

Обзор

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.

Вмешательства

• Процедура 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).
• Процедура 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

Первичные конечные точки

• Rate of type 2 diabetes remission [Срок оценки: at 12 months after surgery]

Вторичные конечные точки (12)

• Absolute weight loss (aWL in kg) [Срок оценки: at 1, 3, 6 and 12 months after surgery]
• Excess Weight Loss percentage (EWL%) [Срок оценки: at 1, 3, 6 and 12 months after surgery]
• Excess BMI Loss percentage (EBL%) [Срок оценки: at 1, 3, 6 and 12 months after surgery]
• Medical and surgical complication rates [Срок оценки: 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 [Срок оценки: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]]
• Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire [Срок оценки: Before surgery and at 12 after surgery]
• Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery. [Срок оценки: Before surgery and at 12 after surgery]
• Change in glucose homeostasis [Срок оценки: Before surgery and at 3, 6 and 12 months after surgery]
• Change in HbA1c [Срок оценки: Before surgery and at 3, 6 and 12 months after surgery]
• Change in fasting glycemia [Срок оценки: Before surgery and at 3, 6 and 12 months after surgery]
• changes in fasting insulinemia [Срок оценки: Before surgery and at 3, 6 and 12 months after surgery]
• change in fasting c-peptide [Срок оценки: Before surgery and at 3, 6 and 12 months after surgery]

Критерии участия

Критерии включения

• BMI ≥ 35 kg/m2
• All patient with type 2 diabetes
• Patients who were candidates for obesity surgery in accordance with French recommendation

Критерии исключения

• Severe cognitive or mental disorders
• patient who have already undergone obesity surgery
• Severe and non-stabilised eating disorders
• The likely inability of the patient to participate in lifelong medical follow-up
• Alcohol or psychoactive substances dependence
• The absence of identified prior medical management of obesity
• Diseases that are life-threatening in the short and medium term;
• Contraindications to general anaesthesia.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• Chu Amiens Picardie — Amiens
• Ch Boulogne-Sur-Me — Boulogne-sur-Mer
• Hop Claude Huriez Chu Lille — Lille
• Ch de Valenciennes — Valenciennes

Идентификаторы

NCT: NCT03821636 · 2017_02 · 2017-A01761-52 · PHRCI-16-090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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