NCT04639726已完成不适用
A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response in Patients with Type 2 Diabetes.
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年9月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Post-prandial glycemic excursion.
研究概览
简要总结
This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to sign written informed consent prior to study entry.
- •Male or female, >18 years of age.
- •Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
- •Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- •Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
- •Patients must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
排除标准
- •Fasting plasma glucose >220mg/dl at screening.
- •Impaired kidney function, epidermal growth factor receptor of <60mL/min/1.73m2 at screening.
- •BMI >40kg/m
- •Elevated liver transaminase > 3 upper limit of normal at screening.
- •Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
- •Ongoing or recent (i.e. < 3month) injectable insulin therapy.
- •Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
- •Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
- •Major medical/surgical event requiring hospitalization in the last 3 months.
- •Known allergy and intolerance to product components or acetaminophen.
- •Alcohol intake higher than 2 servings per day. A serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer.
- •Are unable to comply with protocol procedures in the opinion of the investigator.
- •Have a hierarchical link with the research team members.
- •Positive pregnancy test at screening.
- •Patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial.
- •Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Patients must also agree to not donate blood within 8 weeks after their last visit.
结局指标
主要结局
Post-prandial glycemic excursion.
时间窗: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Incremental area under the curve post-prandial glycemic excursion (iAUC 0-3 hours)
次要结局
- Plasma ghrelin(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma cholecystokinin(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma glucagon(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Beta-cell function I(-15, 0, 30, 60, 90, and 120 minutes.)
- Total glucose(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Serum insulin(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Serum triglycerides(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma glucose(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Plasma Gastric Inhibitory Polypeptide(-15, 0, 30, 60, 90, and 120 minutes.)
- Gastric emptying(-15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes.)
- Beta-cell function II(-15, 0, 30, 60, 90, and 120 minutes.)
- 2h post-prandial glucose(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Plasma peptide(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma Glucagon-like Peptide-1(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
研究者
研究点 (2)
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