NCT04230889已完成不适用
A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 16
- 主要终点
- Interstitial Glucose Response
研究概览
简要总结
A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes as evidenced by the use of metformin, thiazolidinones, or sulfonylureas, alone or in combination, with constant dose for a least 2 months prior to Screening and is able to maintain medication dose throughout the duration of the study
- •A1C ≥ 7.0% and ≤ 10.0%
- •Follows a consistent eating pattern of 3 main meals with snacks
- •BMI ≥ 25.0 and ≤ 40.0 kg/m2
- •Stable body weight for the past 2 months prior to Screening Visit
- •If on thyroid medication or hormone replacement therapy, dose been has been constant for at least 2 months prior to Screening Visit
- •If taking vitamin C supplement >60 mg/d, is willing to discontinue throughout the duration of the study
- •Willing to take non-aspirin pain relievers through the duration of the study
- •Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •Not taking oral anti-hyperglycemic medications (e.g., controlled by diet); is taking other oral anti-hyperglycemic medications other than metformin, thiazolidinones, or sulfonylureas; or on injectable medications (e.g., exenatide, insulin) for glucose control
- •History of diabetic ketoacidosis
- •History of metabolic/endocrine (other than diabetes), hepatic, or significant renal disease
- •Follows a non-typical eating pattern, such as very low carbohydrate diet, strict vegetarianism
- •Currently using diabetes-specific nutritional product(s), defined as more than one eating occasions per week
- •Non-typical or erratic sleep-wake pattern, such as nightshift worker, chronic insomnia
- •Pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration (only applicable to female subjects)
- •Skin lesions, hyperhidrosis, eczema, psoriasis, scarring, tattoos, redness, infection or edema at the application sites that in the opinion of the study investigator or study physician could interfere with device placement or the accuracy of interstitial glucose measurements
- •X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends
- •Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Screening Visit
- •Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma)
- •Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
- •History of bariatric surgery including gastric balloon; history of gastrointestinal disease (e.g., crohns, colitis, celiac) or intestinal surgery that can interfere with consumption/digestion/absorption of study product
- •Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise; including heavy physical labor), duration of 1 hour or longer, 3 or more times per week
- •Known to be allergic or intolerant to any ingredient found in the study products
- •Currently taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite
- •Eating disorder, severe dementia or delirium, 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
- •Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 day follow-up period for such a trial) or that otherwise conflicts with this study
结局指标
主要结局
Interstitial Glucose Response
时间窗: Study Day 1 to Study Day 14
Change versus baseline phase
次要结局
- Postprandial Glucose(Study Day 1 to Study Day 14)
研究者
研究点 (16)
Loading locations...
相似试验
Unknown
不适用
The Mobile Diabetes Mgmt. Study With Type 2 DiabetesType 2 DiabetesNCT02451631Healthconnect184
终止
不适用
SteadiSet™ Pilot Study (SteP Study)Diabetes Mellitus, Type IDiabetes Mellitus, Insulin-Dependent, 1Type 1 DiabetesType 1 Diabetes MellitusIDDMNCT04591925Capillary Biomedical, Inc.13
已完成
4 期
Toujeo Versus NPH Self-titration StudyDiabetes Mellitus, Type 2NCT03389490Elaine Chow50
已完成
不适用
A Study in North Macedonia Investigating Retrospective Data of Glucagon-like Peptide-1 (GLP-1) Participants With Type 2 Diabetes (T2D) in Real World Environment (RWE) Setting (MIRAGE)Diabetes Mellitus, Type 2NCT05468632Novo Nordisk A/S314
已完成
3 期
Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)Type 2 Diabetes MellitusNCT00032487VA Office of Research and Development1,791