A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Delta glucose (maximum rise from baseline glucose) mg/dL
研究概览
简要总结
The aim of this clinical study is to investigate and compare the postprandial glycemic response to three different meal types rich in carbohydrates, that is, white pasta, high protein pasta and white rice consumed by individuals with T1DM.
详细描述
The aim of this clinical study is to investigate and compare the postprandial glycemic response to three different meal types rich in carbohydrates, that is, white pasta, high protein pasta and white rice consumed by individuals with T1DM and to demonstrate that:
- The choice of carbohydrates consumed significantly affects the postprandial glycemic profile in people with type 1 diabetes and
- The consumption of high protein pasta will present a tighter postprandial glycemic response.
Previous studies have evaluated the effect of white pasta and rice on postprandial glycemic response in people with type 1 diabetes. With this study, we aim to expand upon these findings by ensuring that the results can still be applied to more recent commercial food products (pasta, rice), but especially to evaluate the effect of high-protein pasta when compared to regularly consumed carbohydrates (white pasta, white rice).
After consuming the study meal, subjects will participate in an education session (a 2 hour class per each meal challenge session). Classes will be taught by a registered dietician and diabetes & exercise expert and, as appropriate, a culinary instructor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Subjects will not be told which meal they are eating.
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
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years at the time of screening.
- •Clinical diagnosis of type 1 diabetes for at least one year.
- •HbA1c ≤ 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- •Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes, and boluses for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- •Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
- •For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile at the screening visit. Subjects who become pregnant will be discontinued from the study.
- •Willing to abide by the study protocol and use study-provided devices.
排除标准
- •Gastrointestinal disease such as celiac disease or multiple food allergies.
- •Any form of gluten sensitivity or wheat allergy.
- •Allergies to any form of nuts and ingredients present in the study meals (tomatoes etc).
- •History of gastroparesis.
- •Pregnancy.
- •Dermatological conditions that would preclude wearing a CGM sensor.
- •Screening A1c > 10%.
- •Any condition that could interfere with participating in the trial, based on the investigator's judgment.
- •A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
- •Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
研究组 & 干预措施
Regular pasta
Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of regular pasta. They will consume this meal on two separate occasions.
干预措施: Regular pasta (Other)
High protein pasta
Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of high protein pasta. They will consume this meal on two separate occasions.
干预措施: High protein pasta (Other)
White rice
Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of white rice. They will consume this meal on two separate occasions.
干预措施: White rice (Other)
结局指标
主要结局
Delta glucose (maximum rise from baseline glucose) mg/dL
时间窗: 5 hours
Delta glucose (maximum rise from baseline glucose) from the start of the meal to the peak continuous glucose monitoring (CGM) glucose reading (mg/dL) during the 5-hour postprandial window, compared between the three meal types.
次要结局
- Incremental area under the curve (area)(5 hours)
- Time to peak glucose level (minutes)(5 hours)
- percent time glucose <70 mg/dL(5 hours)