Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients (GUATECO)

Centro Universitario de Ciencias de la Salud, Mexico

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Calcinaned magnesia; Drug: Guazuma Ulmifolia plus Tecoma Stans

Study type: Interventional

Funder types: Other

Identifiers

NCT03313856

1111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.

Treatment:

Drug: Calcinaned magnesia

Guazuma ulmifolia plus Tecoma stans

Experimental group

Description:

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.

Treatment:

Drug: Guazuma Ulmifolia plus Tecoma Stans