The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity (PIPC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.
研究概览
简要总结
The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.
In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.
With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.
详细描述
This study will measure the ability of the pancreas to produce insulin after the participant drinks a Boost Original meal replacement shake. The Boost Original meal replacement shake contains nutrients similar to a typical meal, and allows to standardize this "meal" for all participants. This is a cross-sectional study for 90 participants with type 2 diabetes mellitus who undergo a single study visit that lasts 2 hours with blood drawn at five time points. The area under the curve will be a quantitative measure of each participant's pancreatic insulin production capacity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent provided
- •Age >= 18 years.
- •Diagnosed as type 2 diabetes mellitus.
- •Not on insulin therapy.
排除标准
- •Diagnosed as another form of diabetes mellitus.
- •Allergic to one or more ingredients in Boost meal replacement shake.
- •Unable to fast since midnight and attend in person for the morning protocol.
研究组 & 干预措施
Pancreatic insulin production after drinking meal replacement shake
Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity.
干预措施: Boost Original meal replacement shake (Dietary Supplement)
结局指标
主要结局
Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.
时间窗: 12 months
Participants will get blood drawn at time 0, 30, 60, 90, and 120 minutes. Blood will be sent for glucose, insulin, and C-peptide measurements. The area under the curve (AUC) will be calculated from these measurements. The AUC for insulin and for C-peptide will be representative of the participant's PIPC.
次要结局
- The impact of participant's self-reported weight gain in the past year (12 months prior to the single study visit) on participant's PIPC.(12 months)