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OpenTrials
Completed

NCT Number: NCT03313856

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guazuma Ulmifolia plus Tecoma Stans

Drug

Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule

Other names: GUATECO

Calcinaned magnesia

Drug

Calcined magnesia 400 mg per capsule

Other names: Placebo

Primary outcomes

  1. Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans

    Time frame: 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.

  2. Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans

    Time frame: 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 outcomes

  1. Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans

    Time frame: 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.

  2. Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans

    Time frame: 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.

  3. Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile

    Time frame: 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.

  4. Renal safety of administration of guazuma, tecoma through the determination of serum creatinine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Other

Registry information

Acronym: GUATECO

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 18, 2017
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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