NCT04234373进行中（未招募）不适用
Understanding Gut-brain Interactions and the Effect of a Low-carb Dietary Intervention in Obese Patients With and Without Glucose Intolerance or Diabetes: a Pilot Trial
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.
研究概览
简要总结
Effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A: HEALTHY LEAN CONTROLS
- •Healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, HbA1C <5.7% and fasting glucose <5.6 mmol/l
- •Normal eating habits
- •Stable body weight for at least three months
- •Informed Consent as documented by signature
- •Group B: PRE-DIABETIC or DIABETIC OBESE
- •Pre-diabetic/Diabetic obese with a HbA1C >5.7% and/or fasting glucose >5.6 mmol/l) and body-mass index > 30kg/m2, otherwise healthy
- •Normal eating habits
- •Stable body weight for at least three months
- •Informed Consent as documented by signature
排除标准
- •Group A: HEALTHY LEAN CONTROLS
- •Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
- •Pre-existing diet (vegetarian, vegan, gluten-free etc.)
- •Psychiatric illness
- •Alcohol abuse, (smoking allowed)
- •Regular intake of medications, (oral contraceptives allowed)
- •Intake of antibiotics within the last 3 months before inclusion
- •Regular intake of pro- or prebiotics
- •Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
- •Clinically relevant acute or chronic inflammatory disease
- •Pregnancy
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
- •Group B: PRE-DIABETIC or DIABETIC OBESE
- •Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
- •Pre-existing diet (vegetarian, vegan, gluten-free etc.)
- •Psychiatric illness
- •Alcohol abuse, (smoking allowed)
- •Regular intake of medications (except: oral contraceptives, metformin, SGLT-2, statins, and antihypertensive, which are allowed)
- •Intake of antibiotics within the last 3 months before inclusion
- •Regular intake of pro- or prebiotics
- •Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
- •Clinically relevant acute or chronic inflammatory disease
- •Pregnancy
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
研究组 & 干预措施
Low Carb dietary Intervention
Experimental
干预措施: Low Carb diet (Other)
结局指标
主要结局
Effect of a low-carb dietary intervention on glycemic control as defined by blood glucose level at 2h after an oral glucose tolerance test.
时间窗: Change from baseline to 6 months
次要结局
- Effect of a low-carb dietary intervention on liver fat fraction as measured with MRI(Change from baseline to 6 months)
- Effect of a low-carb dietary Intervention on brain network activity as measured with functional MRI(Change from baseline to 6 months)
- Effect of a low-carb dietary intervention on metabolomics as measured in plasma, urine and stool samples(Change from baseline to 6 months)
- Effect of a low-carb dietary intervention on body composition as measured with dual-energy x-ray absorptiometry(Change from baseline to 6 months)
- Effect of a low-carb dietary intervention on gut microbiota composition as measured in stool samples(Change from baseline to 6 months)
研究者
研究点 (1)
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