Hypoglycemic Effect of Cinnamomum Verum in Type 2 Diabetic Patients in the Municipality of Comasagua
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The aim of the study is evaluate the effect of cinnamon powder (Cinnamomum verum) on the glycaemia and HbA1c (Glycohemoglobin) of type 2 diabetic Salvadoran patients, whose hypoglycemic treatment is only Metformin. To carry out this objective, subjects who agree to be part of the study will subjected to measurements of their body weight, height, body mass index, waist circumference, systolic pressure, diastolic pressure, capillary glucose (with glucose meter) every 2 weeks, and their glycohemoglobin (HbA1c) at the beginning and at the end of the study.
详细描述
The study will be conducted for 12 weeks (3 months) with 30 participants diagnosed with type 2 diabetes mellitus, whose only treatment for diabetes is metformin.
Both, intervention with Cinnamon (Cinnamomum verum) and wheat flour (placebo) will be encapsulated in titanium white capsules with 500 mg of powder, that will take place in agro-industry laboratories, and will be packed in glass bottles with a content of 56 capsules and a bag of silica gel.
The data of the probable participants will verified with their medical records in the Intermediate Communitarian Unit of Family Health of Comasagua municipality (UCSFI-Comasagua). Then those who meet the criteria will contacted to be enrolled in the study, if they agreed, an informed consent will signed or stamped if the participant cannot read and write.
The randomization will be make using a list of the participants and them using the Graphpad QuickCalcs option of "Randomly assign participants to groups", assigning the participants to a group A (intervention) or B (placebo).
Participants in both groups will continue to receive the treatment they would normally receive from their respective primary care providers during the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 2 Diabetes mellitus.
- •Treated only with Metformin as unique treatment for diabetes.
排除标准
- •Hypersensitivity or allergy reported to Cinnamomum spp. or Peruvian balm.
- •Ulcer of gastrointestinal location.
- •Chronic treatment with analgesics, antibiotics, estrogens, antineoplastics, antihypertensives of the beta-blocker type, anti-inflammatory, medications whose route of action is Gamma-Aminobutyric Acid and / or anticoagulants.
- •Under treatment with steroid and / or aspirin.
- •Subject that use alternative medicine treatments.
- •Women of childbearing age who do not use any contraceptive method.
- •Subjects subjected to surgical procedures in the 6 weeks prior to the beginning of the study.
- •Subjects who presented fasting glycemia levels greater than 400 mg/dL in the previous control.
- •Allergies to wheat and/or diagnosed with celiac disease.
- •Adverse Drug Reaction during the study.
- •Subjects whose treatment schedule changed during the study intervention.
- •Subjects that does not accept to be part of the study, decides to leave the study or does not have adherence to the treatment provided.
结局指标
主要结局
Change in HbA1c
时间窗: Week 0 and 12
次要结局
- Change in Waist Circumference(Week 0, 2, 4, 6, 8, 10, 12)
- Change in Diastolic pressure(Week 0, 2, 4, 6, 8, 10, 12)
- Change in Capillary Glucose(Week 0, 2, 4, 6, 8, 10, 12)
- Change in Body Mass Index (BMI)(Week 0, 2, 4, 6, 8, 10, 12)
- Change in Systolic Pressure(Week 0, 2, 4, 6, 8, 10, 12)
研究者
Miguel Antonio Padilla Pimentel, MD
Doctor of Medicine
Universidad Dr. José Matías Delgado