Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth (MIGHTY-Fiber)

益生元和二甲双胍影响 2 型糖尿病青少年的肠道和激素 (MIGHTY-Fiber)

• 批准号: 10697864
• 负责人: Stephanie Therese Chung
• 金额: $ 49.84万
• 依托单位: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697864
• 关键词: Abdomen; Address; Adult; Adverse effects; Age; American; Bacteria; COVID-19 pandemic; Chronic; Clinical; Cross-Over Trials; Data; Data Analyses; Diabetes Mellitus; Diarrhea; Diet; Double-Blind Method; Eating; Enrollment; FDA approved; Feces; Fiber; Food; Foundations; Glucose; Hormones; Individual; Insulin; Intervention; Journals; Manuscripts; Marketing; Metformin; Muscle Cramp; Nature; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Oral; Outpatients; Participant; Peer Review; Pharmaceutical Preparations; Phase; Pilot Projects; Placebos; Procedures; Process; Protocols documentation; Randomized; Schedule; Societies; Standardization; Testing; Time; United States National Institutes of Health; Visit; Volatile Fatty Acids; Youth; acceptability and feasibility; clinical center; clinical practice; clinically significant; design; falls; gastrointestinal; gastrointestinal symptom; improved; medication compliance; microbial; microbiome; microbiome therapeutics; open label; polyphenol; prebiotics; recruit; side effect; young adult

Study recruitment began in earnest in February 2020 and was on schedule. However, in March 2020, due to the COVID-19 pandemic, recruitment and protocol procedures were significantly delayed. All study visits were placed on hold on March 13th and recruitment and protocol execution resumed August 2020. In total, we have completed 9 screenings at the NIH Clinical Center and enrolled and studied 6 participants. In addition, in June 2020, we were notified that the study agent supplier company (Microbiome Therapeutics) was sold (to Natures Bounty) and the product was no longer commercially available. Efforts to identify additional supply were unsuccessful. Although Natures Bounty will consider marketing a similar product in Fall 2021, this product is not biosimilar to the study agent used in our MIGHTY Fiber protocol. Additional enrollment was paused in July 2021, because the study agent expired on July 31, 2021. The study was closed to enrollment in August 2021 and data analysis is ongoing. The collected data has provided valuable information on the feasibility and acceptability of the microbiome modulator in youth with type 2 diabetes who are treated with metformin. The feasibility results have been presented nationally at the American Diabetes Association Scientific Sessions in June 2022 and the microbial analysis will be presented at Obesity Society in November 2022. The manuscript is in process and will be submitted to peer-reviewed high impact journal. These pilot data are foundational for designing the larger planned trial of microbial modulation in the treatment of diabetes and obesity in youth.

研究招聘始于2020年2月，并按计划进行。 但是，在2020年3月，由于1920年的大流行，招募和协议程序被显着延迟。所有研究访问均于3月13日搁置，招募和协议执行均恢复了2020年8月。总共我们在NIH临床中心完成了9次放映，并招收并研究了6名参与者。 此外，在2020年6月，我们收到了研究代理供应商公司（微生物组治疗剂）的售出（供出发），并且该产品不再商业上可用。确定额外供应的努力失败了。 尽管Natures Bounty将考虑在2021年秋季营销类似产品，但该产品与我们强大的纤维协议中使用的研究代理人并不生动。 由于研究代理于2021年7月31日到期，因此在2021年7月暂停了额外的入学人数。该研究于2021年8月关闭，并正在进行数据分析。收集的数据提供了有关微生物组调节剂在接受二甲双胍治疗的2型糖尿病青年中的可行性和可接受性的宝贵信息。可行性结果已于2022年6月在美国糖尿病协会的科学会议上呈现，微生物分析将于2022年11月在肥胖学会上介绍。手稿正在进行中，并将提交给PEER回顾的高影响力期刊。这些试点数据是基础，用于设计在青年人治疗糖尿病和肥胖症中微生物调节的较大计划试验。