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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Type 2 Diabetes (T2D) remission.
研究概览
简要总结
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.
详细描述
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.
- 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.
- 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.
- 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.
- Visit 4 (12 months after surgery): The same determinations of visit 1 will be performed 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>45 kg/m2
- •T2D on treatment with hypoglycemic agents alone, insulin or both.
排除标准
- •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.
结局指标
主要结局
Type 2 Diabetes (T2D) remission.
时间窗: 12 months
Number of participants achieving T2D remission (HbA1c \<6.5% without anti-diabetic treatment) in each arm group one year after surgery.
次要结局
- Entero-endocrine hormone GLP-1(12 months)
- Entero-endocrine hormone PYY(12 months)
- Entero-endocrine hormone GIP(12 months)
- Bile salts(12 months)
- Intestinal microbiome(12 months)
- Weight loss(12 months)
- Entero-endocrine hormone Ghrelin(12 months)
- Epicardial fat(12 months)
研究者
Nuria Vilarrasa
Principal Investigator
Hospital Universitari de Bellvitge