Exploring Individual Determinants of postpranDIAl Glucose Response in Type 2 diaBEteS to opTimize Therapeutic Strategies With a Personalized Approach (DIABEST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Post-prandial glucose response
研究概览
简要总结
Postprandial glycemia (PPG) is a relevant determinant of glucose control in people with type 2 diabetes (T2D). Epidemiological and pathophysiological studies indicate that PPG is a better risk predictor for cardiovascular disease and all-cause mortality than fasting plasma glucose. Therefore, both fasting and postprandial glycemia should be targeted to achieve optimal glycemic control and, thus, prevent or reduce the risk of diabetes complications.
Post-prandial glucose response (PGR) cannot be predicted based solely on the meals' carbohydrate content. Recent research using continuous glucose monitoring (CGM) systems has identified different patterns of PGR to a standard meal among both healthy people and individuals with type 1 diabetes. Different contributors to the PGR have emerged, including genotype, hormonal and metabolic factors, phenotype, gut microbiota composition, background diet, sleep habits, physical activity levels.
The present project aims at exploring the PGR in a real-life setting in a cohort of people with T2D, and identifying person-specific factors associated with different postprandial glucose patterns.
To this purpose, 144 individuals with T2D on treatment with diet alone or diet plus metformin will be characterized for their anthropometric, metabolic, and gut-microbiome features and will undergo a one-week observational period through CGM system, while properly recording their food intake, physical activity, and sleep habits. A mixed-nutrient standardized meal will be consumed at home in two occasions by each participant to investigate the intra-individual variability of the PGR. Moreover, in a subgroup of participants (n=60), divided according to anthropometric and metabolic features, hormonal and metabolic response to the standardized meal will be evaluated at the hospital, to explore the contribution of different T2D phenotypes to the PGR.
A further step will be developing a prediction algorithm of PGR based on the intra- and inter-individual factors shown to influence postprandial glucose, able to further optimize the management of T2D with precision therapeutic strategies.
详细描述
The participants will undergo a 7-day observational period and acute postprandial tests with a standardized meal. Before the study initiation, all participants will undergo a screening visit for the assessment of inclusion and exclusion criteria. Participants meeting the inclusion criteria will be instructed to collect a stool sample and will be scheduled for the experimental visit (day 0). At day 0, each participant will arrive at the diabetes clinic in the morning, after a 10-hour fasting, to undergo:
- venous blood sampling for biochemical determinations
- anthropometrics and blood pressure measurements
- body composition evaluation (bioimpedance analysis)
- basal metabolic rate evaluation (indirect calorimetry)
- administrations of questionnaires for the evaluation of lifestyle habits
- positioning of a subcutaneous sensor for continuous glucose monitoring (CGM).
Information regarding characteristics of bowel movements in the day of stool sampling will be collected according to the Bristol stool scale.
The participants will be instructed to consume at home a mixed-nutrient meal at breakfast on the second day and on the last day of the observational period. PGR will be assessed by CGM.
Over the following 7 days, participants will undergo CGM while keeping stable their own dietary and lifestyle habits and will be asked to record the following information by using a dedicated app:
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and post-menopausal women
- •HbA1c ≤ 7.5%
- •Body Mass Index (BMI) 20-39.9 kg/m2
- •Ability to comply with the study protocol activities.
排除标准
- •Any acute or chronic condition possibly influencing the interpretation of the results or possibly worsened because of study participation
- •Pregnancy or breast-feeding
- •Use of antibiotics, probiotics, or prebiotics during the last three months.
结局指标
主要结局
Post-prandial glucose response
时间窗: 7 days (related to the 7-day continuous glucose monitoring)
Post-prandial glucose response will be calculated by the trapezoidal method as the area under the curve above the baseline value (iAUC).
次要结局
- Energy intake(7 days (related to the 7-day continuous glucose monitoring and food record))
- Gut-microbiota composition(7 days (related to the 7-day continuous glucose monitoring))
- Dietary components(7 days (related to the 7-day continuous glucose monitoring and food record))
- Physical activity levels(7 days (related to the 7-day continuous glucose and physical activity monitoring))
- Sleep duration(7 days (related to the 7-day continuous glucose and sleep monitoring))
研究者
rivellese angela
Full Professor
Federico II University