Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Change in glycemic variability
研究概览
简要总结
To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).
详细描述
The plan is to study 24 participants with T2DM, who are otherwise healthy. The study will be double-blinded and randomized. Participants will first attend a screening visit (Visit #1) to determine eligibility. Then, eligible participants will be asked to wear a FreeStyle Libre Pro continuous glucose monitor (CGM) for up to 14 days (Visit #2). After this 14-day CGM session, participants will be randomly assigned (1:1) to one of two groups that will receive: 1) food products containing onyx sorghum (Onyx Group) or 2) food products with wheat flour (Control Group). The diet intervention will last a total of 28 days. Participants will have weekly visits to pick up food and bi-weekly blood draws (no more than 20mL at each visit). They will also be asked to wear the CGM throughout the diet intervention and will record their food intake in a daily food diary to confirm that the diet intervention is being followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 30-65 years
- •A1c < 8.5%
- •BMI > 18.5
排除标准
- •known malignancy, anemia, kidney disease, and/or liver disease
- •untreated thyroid disease
- •uncontrolled hypertension
- •initiation of any anti-diabetes medications within the last 3 months
- •greater than 5% change in weight in the last 3 months
- •current or recent steroid use in the last 3 months
- •for women: pregnancy or breastfeeding
结局指标
主要结局
Change in glycemic variability
时间窗: day 28
The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline.
次要结局
- Changes in BMI(day 28)
- Changes in weight(day 28)
- Change in glucose levels(day 28)