Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Guazuma Ulmifolia plus Tecoma Stans
- Registration Number
- NCT03313856
- Lead Sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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 / m2.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Guazuma ulmifolia plus Tecoma stans 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. Placebo Calcinaned magnesia The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.
- Primary Outcome Measures
Name Time Method Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans 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 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.
- Secondary Outcome Measures
Name Time Method Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans 90 days In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, lipid profile 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.
Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile 90 days The hepatic profile was determined through the serum levels of transaminases in U/L (Glutamic oxalacetic transaminase and Glutamic pyruvic transaminase) after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
Renal safety of administration of guazuma, tecoma through the determination of serum creatinine 90 days The serum creatinine was measured in mg/dL, before and after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans 90 days In both groups (intervention and placebo ) of 20 patients each, all patients with type 2 diabetes mellitus, insulin was measured in uU/mL, 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.