Diabetes Remission and Hypoabsorptive Bariatric Surgery

Официальное название

Prognostic Factors and Predictors of Diabetes Remission in Hypoabsorptive Bariatric Surgery Techniques. Randomized Comparative Study Between Duodenal Switch, Single-Anastomosis Duodenal Switch (SADI-S) and Mini-Gastric Bypass

Обзор

Bariatric surgery is the most effective treatment to achieve type 2 Diabetes Mellitus (DM) remission in patients with severe obesity. However, there is little evidence of the effectiveness and pathophysiological mechanisms involved in metabolic improvement after hypoabsortive tecniques such as duodenal switch (DS), single anastomosis duodenal switch (SADI-S) or minigastric bypass (MGB). We have designed a randomized study to compare type 2 diabetes remission after the 3 bariatric procedures in patients with severe obesity (BMI \> 45kg/m2) and to study the implication of gastrointestinal hormones, bile acids and gut microbiota in metabolic improvement in each procedure.

Подробное описание

Patients fulfilling inclusion criteria will be randomly assigned 1:1:1 to undergo DS, SADI-S or MGB. Allocation of patients will be assigned by simple randomization with stratification according to baseline levels of HbA1c (greater or lower/ equal to 7 %).

Protocol 0. Screening visit: All participants will be required to sign the informed consent, according to the regulations of the Committee of the center. Clinical, analytical, and general physical examination data will be collected and it will be checked the fulfillment of inclusion criteria.

1. Visit 1 (1 week after screening visit): Anthropometrical data will be collected, and general biochemical analytics including HbA1c, lipid profile and nutritional parameters and vitamins will be performed. Also a standard meal test (SMT) will be done with determination of GLP-1, PYY, GIP , and ghrelin, insulin, glucose and succinate concentrations before and during the SMT. A complete body composition study including DEXA, BIA and cardiac resonance to determine epicardia fat will be performed. Feces samples will be collected to determine gut microbiota. Quality of live questionnaire will be provided. 2. Visit2 (1 month after surgery): Glycaemia diaries will be checked. Anthropometrical, general biochemical analysis with determination of HbA1c, lipid profile and nutritional parameters and vitamins will be done. SMT will be performed with determination of GLP-1, PYY, GIP, ghrelin, insulin, glucose. A determination of bile acids will be done before starting the meal test. feces samples will be collected to determine gut microbiota. 3. Visit 3 (3 months after surgery): Glycaemia diaries will be checked. Anthropometrical, general biochemical analysis with determination of HbA1c, lipid profile and nutritional parameters and vitamins will be done. 4. Visit 4 (12 months after surgery): The same determinations of visit 1 will be performed 12 months after surgery.

Вмешательства

• Процедура Duodenal Switch
  Classic Duodenal Switch
• Процедура SADI-S
  SADI-S with a 300cm common channel
• Процедура Minigastric Bypass
  Classic minigastric bypass

Первичные конечные точки

• Type 2 Diabetes (T2D) remission. [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Weight loss [Срок оценки: 12 months]
• Entero-endocrine hormone GLP-1 [Срок оценки: 12 months]
• Entero-endocrine hormone PYY [Срок оценки: 12 months]
• Entero-endocrine hormone GIP [Срок оценки: 12 months]
• Entero-endocrine hormone Ghrelin [Срок оценки: 12 months]
• Bile salts [Срок оценки: 12 months]
• Intestinal microbiome [Срок оценки: 12 months]
• Epicardial fat [Срок оценки: 12 months]

Критерии участия

Критерии включения

• BMI>45 kg/m2
• T2D on treatment with hypoglycemic agents alone, insulin or both.

Критерии исключения

• Type 1 diabetes
• Positivity for GAD auto-antibodies
• Secondary forms of diabetes
• Acute metabolic complications in the last 6 months
• Severe liver disease
• Renal dysfunction
• Patients under anticoagulant treatment
• Previous bariatric surgery
• Congenital or acquired abnormalities of the digestive tract
• Pregnancy
• Nursing or desired pregnancy in the 12 months following inclusion
• Corticoid use by oral or intravenous route for more than 14 consecutive days in the last three months.

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

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Публикации

• Finno P, Osorio J, Garcia-Ruiz-de-Gordejuela A, Casajoana A, Sorribas M, Admella V, Serrano M, Marchesini JB, Ramos AC, Pujol-Gebelli J. Single Versus Double-Anastomosis Duodenal Switch: Single-Site Comparative Cohort Study in 440 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3309-3316. doi: 10.1007/s11695-020-04566-5. PMID 32240495
• Gebelli JP, Lazzara C, de Gordejuela AGR, Nora M, Pereira AM, Sanchez-Pernaute A, Osorio J, Sobrino L, Garcia AJT. Duodenal Switch vs. Single-Anastomosis Duodenal Switch (SADI-S) for the Treatment of Grade IV Obesity: 5-Year Outcomes of a Multicenter Prospective Cohort Comparative Study. Obes Surg. 2022 Dec;32(12):3839-3846. doi: 10.1007/s11695-022-06317-0. Epub 2022 Oct 25. PMID 36282430

Идентификаторы

NCT: NCT06043245 · PR015/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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