NCT05129735撤回不适用
An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
Teatis, Inc2 个研究点 分布在 1 个国家开始时间: 2022年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Improvement of quality of life score from baseline to 12-weeks
研究概览
简要总结
This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female between 18-75 years old
- •Diagnosed with type 2 diabetes for at least 3 months
- •HbA1c of 7.5 to 10% inclusive
- •BMI of 27 to 40 kg/m2
- •If on any medication, treated with a stable dose for at least 90 days
- •Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- •Willing and able to provide written informed consent
- •Must have a Glucometer at home
排除标准
- •Diagnosis of type 1 diabetes
- •Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
- •Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
- •Allergies to any test product ingredients
- •Has any of the following medical conditions:
- •Oncological conditions
- •Psychiatric disease
- •Cardiovascular disease: any hospitalization within the past 3 months
- •Multiple Sclerosis
- •Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.
- •Any other severe chronic disease
- •History of drug or alcohol abuse
- •Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study
- •Participation in a clinical research trial within 30 days prior to screening
- •Participating in an investigational health product research study
- •Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol
结局指标
主要结局
Improvement of quality of life score from baseline to 12-weeks
时间窗: 12 weeks
Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)
次要结局
- Improvement in total cholesterol levels from baseline to 12-weeks(12 weeks)
- Improvement in triglyceride levels from baseline to 12-weeks(12 weeks)
- Improvement in HDL cholesterol levels from baseline to 12-weeks(12 weeks)
- Improvement in a1c levels from baseline to 12-weeks(12 weeks)
- Improvement in blood glucose from baseline to 12-weeks(12 weeks)
- Improvement in insulin levels from baseline to 12-weeks(12 weeks)
- Improvement in LDL cholesterol levels from baseline to 12-weeks(12 weeks)
研究者
研究点 (2)
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