Impact of a Specific Micronutrient-probiotic-combination on Fatty Liver and Cardiometabolic Status of Obese Patients After Mini-Gastric Bypass Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in alanine-aminotransferase (ALAT) activity in serum
研究概览
简要总结
Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese, nonalcoholic fatty liver disease (NAFLD) patients after Mini-Gastric Bypass (MGB) surgery.
详细描述
Background:
The increasing prevalence of obesity and diabetes mellitus seems to reach epidemic proportions worldwide. In particular visceral obesity in combination with impaired glucose tolerance is associated with risk for progression of a broad spectrum of cardiometabolic diseases such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease and non-alcoholic fatty liver disease (NAFLD). Thus, among patients undergoing bariatric surgery more than 95% have NAFLD, with nonalcoholic steatohepatitis (NASH) being present in 32-39 %.
Only bariatric surgery currently seems to attain long-term weight loss in morbidly obese patients. In addition, greater success in terms of improvement in obesity related comorbidities and reduction of overall-mortality can be achieved by surgical measures. Recent data indicate that Mini-Gastric Bypass (MGB) is an effective procedure for weight loss and reduction of comorbidities. Although weight loss is usually recommended as therapy for obesity with NAFLD and NASH, not all NAFLD patients benefit from surgical induced weight loss as indicated by increase in transaminase activity. An optimized micronutrient in combination with a probiotic supplementation could be a useful tool to prevent the transition from NAFLD to NASH.
Aim:
Therefore this study aims to elucidate the effect of a specific micronutrient-probiotic-combination on fatty liver and insulin resistance in obese patients after MGB surgery. Furthermore, this study aims to help optimizing the dietary food supplementation after MGB to reduce the progress of NAFLD/NASH and cardiometabolic diseases.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects 20-65 years old
- •BMI ≥ 35 kg/m² to ≤ 50 kg/m²
- •Fatty Liver Index ≥ 60
排除标准
- •subjects with anamnestic known alcoholic-fatty liver disease, hepatitis B, hepatitis C, HIV/ AIDS
- •subjects with chronic conditions such as active malignant disease, inflammatory bowel disease and other systemic inflammatory conditions
- •supplementation with dietary supplements or drugs which contain probiotics, milk thistle, fatty acids, vitamins or minerals 4 weeks before bariatric surgery
- •treatment with psychotropic drugs
- •diabetic patients who are treated with antidiabetic medications
- •use of antibiotic 4 weeks before bariatric surgery
- •weight gain during run-in phase of more than 5 %
- •in women of childbearing age, pregnancy or breastfeeding
- •no safe method of contraception in women of childbearing age
结局指标
主要结局
Change in alanine-aminotransferase (ALAT) activity in serum
时间窗: Baseline and 12 weeks
ALAT in U/l
次要结局
- Change in fasting glucose concentration(Baseline and 12 weeks)
- Change in Fatty Liver Index (FLI)(Baseline and 12 weeks)
- Change in nonalcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS)(Baseline and 12 weeks)
- Change in resting blood pressure(Baseline and 12 weeks)
- Change in heart rate(Baseline and 12 weeks)
- Change in glycated haemoglobin (HbA1c)(Baseline and 12 weeks)
- Change in homeostatic model assessment (HOMA) of insulin resistance (IR) (HOMA-IR)(Baseline and 12 weeks)
- Change in fasting insulin concentration(Baseline and 12 weeks)
研究者
Karl Peter Rheinwalt
Scientific Adviser for Visceral- and Metabolic Surgery
Bonn Education Association for Dietetics r.A., Cologne, Germany