Development of rice-based medical food for patients with diabetes mellitus: Clinical study of medical food efficacy in diabetes mellitus or prediabetes patients

Agricultural Research Development Agency (ARDA)0 个研究点目标入组 30 人开始时间: 2021年7月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. aged 18-60 years old
•2. body mass index between 25-35 kg/m2
•3. diagnosed with diabetes within 6 years of enrollment OR diagnosed with prediabetes either by fasting plasma glucose >=126 mg/dL or HbA1c >=5.7%
•3. diabetes is being treated by lifestyle therapy alone or in conjunction with oral glucose-lowering drugs

•1. receives insulin
•2. prior history of gastroparesis
•3. HbA1c >9% or diagnosed with diabetes >6 years prior to enrollment
•4. blood pressure >= 180/110 mmHg or triglyceride levels >500 mg/dL
•5. prior history of severe hyperglycemic or severe hypoglycemic episodes requiring hospitalization within 1 year of enrollment
•6. severe medical problems requiring ongoing treatment, including but not limited to cancer, cardiac, pulmonary, hepatic, brain diseases or severe infections within 1 year of enrollment
•7. history of surgery or hospitalization within 2 weeks of enrollment
•8. history of allergy to medical foods (or its components) used in this study
•9. body weight change of 5kg or more within 6 weeks of enrollment
•10. pregnancy and lactation
•11. prior history of bariatric surgery
•12. diagnosis of diseases which significantly affect food digestion and absorption such as inflammatory bowel disease, Crohn's disease, ulcerative colitis

发起方

Agricultural Research Development Agency (ARDA)