Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
研究概览
简要总结
To evaluate the effect of oral administration of herbarium mixture Guazuma ulmifolia (GU) and Tecoma stans (TS) on metabolic profile in type 2 diabetic patients.
详细描述
A randomized, double blind, placebo controlled, clinical trial was carried out 40 type 2 diabetic patients independently of their basal hypoglycemic treatment. At beginning and at end of the study, BMI, waist circumference, a metabolic profile (fasting glucose, HbA1c, lipids and biosecurity profile), were measured. The patients were randomly assigned to receive the herbarium mixture (GU/TS) 1 g before each meal, or placebo for a period of 90 days. All patients received therapy medical nutrition.
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, Investigator)
盲法说明
Simple random. It was done with a table of numbers using random selection program Excel 2010.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of letter of consent under written information.
- •Men and women with serum glucose of ≥126 and <400 mg / dl and / or HbA1c ≥6.5% and <10%.
- •Age between 30 and 60 years.
- •BMI between 25 - 39.9 kg / m
- •With or without pharmacological treatment with oral hypoglycemic agents or insulin
- •Stable body weight during the last 3 months (± 5%).
- •Women in the follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of the laboratory tests
- •Women who do not expect to be pregnant within the next 3 months.
排除标准
- •Physical or mental incapacity that makes it impossible to carry out the intervention.
- •Uncontrolled thyroid disease
- •Women with suspicion or confirmation of pregnancy.
- •Women who are breastfeeding.
- •Hepatic disease or elevation to double the upper normal value of TGO and TGP.
- •Diagnosis of renal insufficiency or creatinine> 1.5 mg / dL or glomerular filtration rate <60 mL / min).
- •Known hypersensitivity to calcined magnesia or Guazuma ulmifolia and / or Tecoma stans.
研究组 & 干预措施
Placebo
The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.
干预措施: Calcinaned magnesia (Drug)
Guazuma ulmifolia plus Tecoma stans
The patients were randomly assigned to received the herbarium mixture (GU/TS) , 1 capsule of 400mg, before each meal for a period of 90 days.
干预措施: Guazuma Ulmifolia plus Tecoma Stans (Drug)
结局指标
主要结局
Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
时间窗: 90 days
In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, glucose was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
时间窗: 90 days
In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, HbA1c was measured in %, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
次要结局
- Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans(90 days)
- Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile(90 days)
- Renal safety of administration of guazuma, tecoma through the determination of serum creatinine(90 days)
- Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans(90 days)
研究者
Maria Guadalupe Ramos Zavala
Clinical Professor
Centro Universitario de Ciencias de la Salud, Mexico