Effect of Fermentable Carbohydrate on Glucose Homeostasis and Weight Management in Subjects With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Glycaemic Control
研究概览
简要总结
The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity. Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads to improved insulin sensitivity. This body of work will examine the effect of fermentable carbohydrate on appetite, weight loss, blood glucose control which will give an indication of the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.
详细描述
TITLE The Effect of Fermentable Carbohydrate on Weight Management and Glycaemic Control in People at High Risk of Developing DMT2
AIMS To assess the effect of fermentable carbohydrate in subjects with pre-diabetes on:
- Appetite regulation
- Glucose homeostasis and B-cell function
- Weight loss and changes in body composition
- Weight loss maintenance
- Markers of Oxidative Stress
DESIGN The investigators plan to conduct 3 investigations. Investigation 1 and 2 are Randomised Crossover Control Trials of 14 days supplementation with 30g of inulin (fermentable carbohydrate) or a cellulose (non fermentable carbohydrate) control to firstly describe the physiology and mechanisms behind appetite regulation and glucose homeostasis. Investigation 3 is a Randomised Control Parallel Study of weight loss followed by weight maintenance to assess the efficacy of fermentable carbohydrate to decrease risk of T2DM.
POPULATION Overweight and obese men or women with pre-diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigation 1 and 3: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose<7.0mmol/l and a 2-h plasma glucose ≥7.8 and <11.1mmol/l and/or impaired fasting glucose, defined by the American Diabetes Association as a fasting plasma glucose of >5.6 and <6.9mmol/L.
- •Investigation 2: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose<7.0mmol/l and a 2-h plasma glucose ≥7.8 and <11.1mmol/l. For investigation 2, people with only IFG will be excluded.
- •All investigations:
- •Adults over 18 years of age
- •Males and Females with a BMI between 25-35 kg/m
- •The BMI range of between 25-35Kg/m2 has been chosen as this is the range that the majority of overweight people fall into (1). At this level of overweight and obesity there is an increase in the risk of type 2 diabetes. Above 40 kg/m2 there appears to be decreased success with lifestyle advice.
- •The volunteers should have given full written consent.
- •Have had a stable body weight for the last 6 months with no more than a 5% change in body weight over 6 months.
排除标准
- •Adults less than 18 years of age.
- •Volunteers with a major metabolic disease - including diabetes.
- •A normal oral glucose tolerance test or that diagnostic of diabetes by the WHO criteria.
- •Pregnant and lactating women.
- •Males and Females with a BMI less than 25kg/m2 or greater than 35kg/m2
- •Volunteers unable to give informed consent for themselves.
- •Has lost or gained 5% of their normal body weight in the last 6 months.
- •Has a known/diagnosed gastrointestinal problem such as inflammatory bowel disease, irritable bowel syndrome etc
- •Failure of the medical examination for inclusion into the study
- •Those with anaemia (Hb <10g/l)
- •Drug or alcohol abuse in the last 2 years.
结局指标
主要结局
Glycaemic Control
时间窗: 9 weeks
An oral glucose tolerance test (OGTT) using 75 g of glucose was performed to clarify glycaemic status.
次要结局
- Food Intake in Gram at 9 Weeks(9 weeks)