NCT05963594已完成不适用
A Randomized, Double-Blind, Comparator-Controlled, Crossover Study to Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With Type 2 Diabetes (T2D) and in Otherwise Healthy Adults With Overweight or Obesity (HAO)
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年1月23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
- 44
- 试验地点
- 2
- 主要终点
- Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.
研究概览
简要总结
The goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy adults with overweight or obesity (HAO).
详细描述
The main question it aims to answer is how consumption of Oligomalt, a slowly digestible carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative to Glucidex 40.
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
- •Type 2 Diabetes (T2D)
- •Inclusion criteria:
- •Willing and able to sign written informed consent prior to study entry.
- •Male or female, >18 years of age.
- •Established diagnosis of T2D (documented by either HbA1c 6.5 - 10.0% or a history of T2D diagnosis).
- •Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- •Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
- •Participants 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
- •Type 1 diabetes.
- •Known food allergy or intolerance to study products.
- •Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
- •Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
- •Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures 4 weeks prior to dosing.
- •Current use of injectable insulin therapy, any other oral (other than metformin) or injectable glucose-lowering drug. Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
- •Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
- •Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
- •Recent episode of an acute gastrointestinal illness.
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.
- •Current daily cigarette smoking.
- •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 or breast-feeding at screening.
- •Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
- •Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
- •Otherwise Healthy Adults (HAO) with overweight or obese but who DO NOT present with a confirmed diagnosis of diabetes mellitus
- •Inclusion criteria:
- •Willing and able to sign written informed consent prior to study entry.
- •Male or female, >18 years of age.
- •BMI ≥ 25 kg/m
- •Fasting plasma glucose (FPG) ≤ 125 mg/dL.
- •Exclusion criteria:
- •Type 1 or type 2 diabetes (including those potentially detected at screening).
- •2-h plasma glucose ≥ 200 mg/dL - if measured within 6 weeks prior to screening.
- •Known food allergy or intolerance to study products.
- •Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
- •Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
- •Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior to dosing.
- •Current use of injectable insulin therapy, any oral or injectable glucose-lowering drug.
- •Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
- •Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
- •Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
- •Recent episode of an acute gastrointestinal illness.
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.
- •Current daily cigarette smoking.
- •Are unable to comply with protocol procedures in the opinion of the investigator.
- •Positive pregnancy test or breast-feeding at screening.
- •Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
- •Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
结局指标
主要结局
Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.
时间窗: Over the course of 3 hours following study product intake
Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40.
次要结局
- Blood glucose (Tmax)(Over the course of 3 hours following study product intake)
- Blood glucose (Cmin)(Over the course of 3 hours following study product intake)
- Number of participants with glucose levels less than or equal to 3.1 mmol/L(Over the course of 3 hours following study product intake)
- Insulinogenic index (IGI)(30 minutes)
- Total blood glucose AUC(Over the course of 3 hours following study product intake)
- Blood glucose (Tmin)(Over the course of 3 hours following study product intake)
- Insulin index(Over the course of 2 hours following study product intake)
- Blood glucose (iCmax)(Over the course of 3 hours following study product intake)
- Serum insulin level(Over the course of 3 hours following study product intake)
- Matsuda Index (MI)(Over the course of 2 hours following study product intake)
- Plasma glucagon-like peptide 1 (GLP-1)(Over the course of up to 3 hours following study product intake)
- Number of participants with glucose levels less than or equal to 3.9 mmol/L(Over the course of 3 hours following study product intake)
- Plasma peptide tyrosine (PYY)(Over the course of up to 3 hours following study product intake)
研究者
研究点 (2)
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