NCT02923960已完成不适用
Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Plasma Glucose Concentration
研究概览
简要总结
This is a randomized, double blinded, multi treatment, crossover study intended to compare the glycemic and insulinemic response after consuming liquid nutritional products in people 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has type 2 diabetes
- •Subject is a male or a nonpregnant, nonlactating female, at least 6 weeks postpartum prior to screening visit
- •Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2
- •If on a chronic medication such as antihypertensive, lipid lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit
- •Subject states willingness to follow protocol as described, including consumption of study product per protocol and completing any required study forms
- •Participant must refrain from taking medications/dietary supplements/herbals or substances that could modulate glucose metabolism (other than oral hypoglycemic medications), or considered anabolic, or reduce weight (fat mass)
排除标准
- •Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Subject is known to be allergic or intolerant to any ingredient found in the study products
- •Subject is participating in another study that has not been approved as a concomitant study
- •Subject uses exogenous insulin for glucose control, or subject states that they have been diagnosed as having Type 1 diabetes
- •Subject states they have a history of diabetic ketoacidosis
- •Subject is currently on a low carbohydrate or very low carbohydrate diet
- •Subject states that he/she has a current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit
- •Subject states that he/she has an active malignancy
- •Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure
- •Subject states that he/she has end stage organ failure or is status post organ transplant
- •Subject is diagnosed with chronic kidney disease, or a history of kidney issues
- •Subject states they have impaired liver function, or have a history of liver disease
- •Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, or ischemic colitis, or any other related condition that may cause unnecessary subject discomfort
- •Subject states they have a chronic, contagious, infectious disease
- •Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that are designed to affect blood glucose.
- •Subject states that he/she has clotting or bleeding disorders
- •If selected for continuous blood glucose monitoring, subject has skin lesions, hyperhidrosis, eczema, psoriasis, scarring, redness, infection or edema at the flash constant glucose monitoring application site(s) that could interfere with device placement or the accuracy of interstitial glucose measurements.
- •If selected for continuous blood glucose monitoring, subject has an X-ray, MRI or CT appointment scheduled during the period of study participation, or another procedure that would require removal of the flash constant glucose monitoring sensor.
- •Subjects on sulfonylureas, meglitinides, and α-glucosidase inhibitors, insulin, or subject on more than two oral hypoglycemic medications excluding aforementioned.
- •Subjects on oral hypoglycemic medications that has changed in last 2 months.
- •Subject's HbA1c, per point of care device is > 8%
研究组 & 干预措施
Standard ONS
Active Comparator
liquid oral nutritional supplement
干预措施: Standard ONS (Other)
Diabetes specific ONS 1
Experimental
liquid oral nutritional supplement with novel carbohydrate blend
干预措施: Diabetes specific ONS 1 (Other)
Diabetes specific ONS 2
Active Comparator
liquid oral nutritional supplement with novel carbohydrate blend
干预措施: Diabetes specific ONS 2 (Other)
结局指标
主要结局
Plasma Glucose Concentration
时间窗: 0 to 240 minutes
次要结局
- Serum Insulin Concentration(0 to 240 minutes)
研究者
研究点 (2)
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