NCT06327711撤回不适用
Proof of Concept Study: Long-term Benefits of a Blend of Nutritional Ingredients for Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Matsuda Index
研究概览
简要总结
This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements.
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)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has type 2 diabetes
- •Taking a maximum of 3 oral anti-diabetic drugs, one must be Metformin.
- •HbA1c ≥ 6.5% and ≤ 9.5% based on blood sample obtained at Screening Visit
- •BMI > 27.0 and < 35.0 kg/m2
- •Weight is stable for the two months prior to Baseline visit
- •Either male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to Baseline Visit
- •If on chronic medication type and dose were constant for at least two months prior to the baseline Visit, and medication will continue throughout the study
- •Willingness to follow the protocol as described, including consumption of study product and completing any forms/questionnaires needed throughout the study
- •Four-week washout period between completion of a previous research study that required ingestion of any study food or drug and start in current study
- •The participant is willing to refrain from taking non-study diabetes-specific oral nutritional formulas during the study
排除标准
- •Use of exogenous insulin or GLP1 agonists
- •Follows a non-typical eating pattern such as very low carbohydrate diet
- •Pregnant or attempting to conceive
- •Confirmed type 1 diabetes and/or history of diabetic ketoacidosis
- •Current infection inpatient surgery or received systemic corticosteroid treatment in last 3 months; or received antibiotics in last 3 weeks
- •Has current active malignant disease or treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma
- •Significant cardiovascular event within 6 months prior or history of congestive heart failure
- •End-stage organ failure or is post-organ transplant
- •Current or history of renal disease, on dialysis or severe gastroparesis
- •Diagnosed hepatic disease or late stage liver fibrosis. Participants with prevalent angina will not be excluded.
- •Had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery
- •Chronic, contagious, infectious disease
- •Eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or any other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Taking any herbals, dietary supplements, or medications during the past four weeks prior to baseline visit that could profoundly affect blood glucose, body weight, muscle, metabolism, appetite or microbiome incretin mimetics, other drugs indicated for weight loss, cannabis, glucocorticoids, probiotic supplements). Those who have stopped using such supplements/ medications for ≥4 weeks prior to baseline need not be excluded).
- •Using diabetes-specific oral nutritional supplements(s), defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded)
- •Actively enrolled in a weight loss program
- •Clotting or bleeding disorders
- •Blood or blood-related diseases
- •Blood transfusion within the last 3 weeks
- •Allergic or intolerant to any ingredient found in the study products
- •Engages in strenuous exercise duration of 1 hour or longer, 3 or more times per week
- •Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
- •Participant has skin lesions hyperhidrosis, eczema, psoriasis, scarring, tattoos, redness, infection or edema at the application sites that could interfere with device placement or accuracy of interstitial glucose measurements
结局指标
主要结局
Matsuda Index
时间窗: Baseline to week 12
Change in insulin sensitivity
Fasted Glucose
时间窗: Baseline week 4, week 8 and week 12
Change in fasted glucose levels overtime
Fasted Insulin
时间窗: Baseline week 4, week 8 and week 12
Change in fasted insulin levels overtime
次要结局
- Body Composition Measurements(Baseline up to 12 weeks)
- Resting Energy Expenditure (REE)(Baseline to week 12)
- Conicity Index(Baseline up to 12 weeks)
- Body Weight(Baseline up to 12 weeks)
- Continuous Glucose Monitoring(Baseline, week 1 to week 2, week 11 and 12)
- Microbiome - Fecal(Baseline week 2, week 4, week 8 and week 12)
- Microbiome - Saliva(Baseline week 2, week 4, week 8 and week 12)
- Glycated Hemoglobin(Baseline week 4, week 8 and week 12)
- Waist Circumference(Baseline up to 12 weeks)
- Hip Circumference(Baseline up to 12 weeks)
研究者
研究点 (2)
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