A Weight Neutral, High Protein, Moderate Carbohydrate Diet for Treatment of Type 2 Diabetes Mellitus

用于治疗 2 型糖尿病的中性、高蛋白、适量碳水化合物饮食

• 批准号: 10373962
• 负责人: Anne E Bantle
• 金额: $ 20.01万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10373962
• 关键词: Achievement; American; Biological Availability; Blood Glucose; Body Weight Changes; Body Weight decreased; Caloric Restriction; Carbohydrates; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Investigator; Clinical Research; Consumption; Creatinine; Cross-Over Trials; Data; Data Analyses; Development; Development Plans; Diabetes Mellitus; Diet; Diet Records; Dietary Intervention; Dietitian; Disease; Endocrinologist; Enrollment; Environment; Fasting; Food; Fructosamine; Funding; Future; Glucose; Glycosylated hemoglobin A; Goals; Home; Hour; Instruction; Interdisciplinary Study; Intervention; Lead; Link; Master' s Degree; Measures; Mentors; Metadata; Minnesota; Modeling; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nitrogen; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Participant; Patients; Persons; Plasma; Positioning Attribute; Principal Investigator; Proteins; Quality of life; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Recommendation; Research; Research Personnel; Research Project Grants; Resources; Role; Scientist; Starch; Surveys; Taxonomy; Testing; Training; Universities; Urine; Weight; Work; career; career development; cost effective; design; dietary control; effective therapy; effectiveness testing; effectiveness trial; efficacy study; experience; glucose metabolism; glycemic control; gut microbiome; insulin secretion; meetings; men; microbiome; microbiome analysis; microbiome composition; mortality; primary outcome; research and development; research study; response; satisfaction; skills; tool

PROJECT SUMMARY Type 2 diabetes mellitus (DM2) causes significant morbidity and mortality. Diet can be a powerful tool for treatment of DM2, but the potential impact of diet has not been fully realized, which may be because usual recommendations include the challenging goals of caloric restriction and weight loss. An isocaloric, moderate carbohydrate, high protein diet (the Low Biologically Available Glucose, or LoBAG, diet) has been designed specifically for people with DM2, and is unique because it does not require caloric restriction or weight loss to produce beneficial effects. Data from preliminary efficacy studies are exciting, but are limited in generalizability. The purpose of the proposed project is to expand generalizability by testing the effectiveness of the LoBAG diet in people with DM2 who are free-living (given diet instruction and asked to prepare their own food). This project is proposed as a key component of a five-year career development plan for Dr. Anne Bantle, an endocrinologist and early career investigator at the University of Minnesota. Dr. Bantle’s long-term goal is to become an independent clinician investigator with expertise in treatment of DM2, with particular focus on diet and the gut microbiome. Her career development plan will allow her to 1) develop expertise in clinical research as a principal investigator, 2) develop expertise in DM2, diet, and gut microbiome, 3) develop skills necessary to lead an interdisciplinary research team, and 4) generate preliminary data to support future funding applications. Specific career development activities will include completion of a Master’s Degree in Clinical Research, hands- on training through implementation of the proposed research study and as a co-investigator in multicenter clinical trials, instruction in gut microbiome analysis, attendance and participation in research meetings, and ultimately, successful application for independent funding. The proposed research project will test the hypothesis that the LoBAG diet is effective in free-living participants with DM2, and specifically that consumption of the LoBAG diet will result in greater reduction of hemoglobin A1c than consumption of a control diet, without requiring caloric restriction or weight loss. Thirty-eight participants will be enrolled in a randomized controlled clinical trial of the LoBAG diet versus a control diet over a 12-week intervention period. Specific aims are to 1) determine the effect of the LoBAG diet compared to control on glycemic control, 2) determine the effect of the LoBAG diet compared to control on compliance and quality of life, and 3) determine if features of the gut microbiome are predictive of glycemic response to diet. It is anticipated that this project will generate preliminary data for a future larger, definitive effectiveness trial. The skills and expertise gained from the proposed career development plan and research project will allow Dr. Bantle to successfully emerge as an independent investigator, and will lay the groundwork for her to become a leading scientist in the field of DM2, diet, and gut microbiome.

项目摘要 2型糖尿病（DM 2）引起显著的发病率和死亡率。饮食可以是一个强大的工具， 治疗DM 2，但饮食的潜在影响尚未完全实现，这可能是因为通常 建议包括限制热量和减肥的挑战性目标。一个等热量的，适度的 碳水化合物，高蛋白饮食（低生物可利用葡萄糖，或LoBAG，饮食）已被设计 特别是对于DM 2患者，它是独一无二的，因为它不需要热量限制或减肥， 产生有益的效果。来自初步疗效研究的数据令人兴奋，但普遍性有限。 拟议项目的目的是通过测试LoBAG饮食的有效性来扩大普遍性 在自由生活的2型糖尿病患者中（给予饮食指导并要求自己准备食物）。 该项目是作为安妮·班特尔博士五年职业发展计划的一个关键组成部分提出的， 他是明尼苏达大学的内分泌学家和早期职业调查员。班特尔博士的长期目标是 成为一名独立的临床研究者，在治疗DM 2方面具有专业知识，特别关注饮食 和肠道微生物组。她的职业发展计划将使她能够1）发展临床研究方面的专业知识 作为主要研究者，2）发展DM 2，饮食和肠道微生物组的专业知识，3）发展必要的技能， 领导一个跨学科的研究团队，以及4）生成初步数据，以支持未来的资金申请。 具体的职业发展活动将包括完成临床研究硕士学位，动手- 通过实施拟议研究进行培训，并作为多中心临床研究的合作研究者 试验，指导肠道微生物组分析，出席和参与研究会议，最终， 成功申请独立资助。 拟议的研究项目将测试LoBAG饮食对自由生活参与者有效的假设 DM 2，特别是LoBAG饮食的消费将导致血红蛋白A1 c的更大降低 而不需要限制热量或减轻体重。38名参与者 将入组LoBAG饮食与对照饮食的随机对照临床试验，为期12周， 干预期。具体目的是：1）确定LoBAG饮食与对照相比对 血糖控制，2）确定LoBAG饮食与对照相比对依从性和质量的影响， 3）确定肠道微生物组的特征是否可预测对饮食的血糖反应。预计 该项目将为未来更大规模的确定性有效性试验提供初步数据。 从建议的职业发展计划和研究项目中获得的技能和专业知识将使博士。 班特尔成功地成为一名独立调查员，并将为她成为一名 DM 2，饮食和肠道微生物组领域的领先科学家。