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

Type 2 Diabetes Mellitus Clinical Trial

— GUATECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313856
• Other study ID #: 1111
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 27, 2017
• Last updated: October 17, 2017
• Start date: January 10, 2010
• Est. completion date: May 31, 2011

Study information

• Verified date: October 2017
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2011
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Guazuma Ulmifolia plus Tecoma Stans
Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
• Calcinaned magnesia
Calcined magnesia 400 mg per capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

References & Publications (13)

Alarcon-Aguilara FJ, Roman-Ramos R, Perez-Gutierrez S, Aguilar-Contreras A, Contreras-Weber CC, Flores-Saenz JL. Study of the anti-hyperglycemic effect of plants used as antidiabetics. J Ethnopharmacol. 1998 Jun;61(2):101-10. — View Citation

Alonso-Castro AJ, Salazar-Olivo LA. The anti-diabetic properties of Guazuma ulmifolia Lam are mediated by the stimulation of glucose uptake in normal and diabetic adipocytes without inducing adipogenesis. J Ethnopharmacol. 2008 Jul 23;118(2):252-6. doi: 10.1016/j.jep.2008.04.007. Epub 2008 Apr 12. — View Citation

Andrade-Cetto A, Heinrich M. Mexican plants with hypoglycaemic effect used in the treatment of diabetes. J Ethnopharmacol. 2005 Jul 14;99(3):325-48. Review. — View Citation

Cano JH, Volpato G. Herbal mixtures in the traditional medicine of eastern Cuba. J Ethnopharmacol. 2004 Feb;90(2-3):293-316. — View Citation

Eddouks M, Bidi A, El Bouhali B, Hajji L, Zeggwagh NA. Antidiabetic plants improving insulin sensitivity. J Pharm Pharmacol. 2014 Sep;66(9):1197-214. doi: 10.1111/jphp.12243. Epub 2014 Apr 15. Review. — View Citation

Frei B, Baltisberger M, Sticher O, Heinrich M. Medical ethnobotany of the Zapotecs of the Isthmus-Sierra (Oaxaca, Mexico): documentation and assessment of indigenous uses. J Ethnopharmacol. 1998 Sep;62(2):149-65. Review. Erratum in: J Ethnopharmacol 1999 Mar;64(3):289-90. — View Citation

Kaufman RJ. Beta-cell failure, stress, and type 2 diabetes. N Engl J Med. 2011 Nov 17;365(20):1931-3. doi: 10.1056/NEJMcibr1109442. — View Citation

Leonti M, Sticher O, Heinrich M. Medicinal plants of the Popoluca, México: organoleptic properties as indigenous selection criteria. J Ethnopharmacol. 2002 Aug;81(3):307-15. — View Citation

Román-Ramos R, Flores-Sáenz JL, Partida-Hernández G, Lara-Lemus A, Alarcón-Aguilar F. Experimental study of the hypoglycemic effect of some antidiabetic plants. Arch Invest Med (Mex). 1991 Jan-Mar;22(1):87-93. — View Citation

Saisho Y. ß-cell dysfunction: Its critical role in prevention and management of type 2 diabetes. World J Diabetes. 2015 Feb 15;6(1):109-24. doi: 10.4239/wjd.v6.i1.109. Review. — View Citation

Tukappa N K A, Londonkar RL, Nayaka HB, Kumar C B S. Cytotoxicity and hepatoprotective attributes of methanolic extract of Rumex vesicarius L. Biol Res. 2015 Mar 25;48:19. doi: 10.1186/s40659-015-0009-8. — View Citation

Wang JJ, Zhao R, Liang JC, Chen Y. The antidiabetic and hepatoprotective effects of magnolol on diabetic rats induced by high-fat diet and streptozotocin. Yao Xue Xue Bao. 2014 Apr;49(4):476-81. — View Citation

Zhang JG, Liu Q, Liu ZL, Li L, Yi LT. Antihyperglycemic activity of Anoectochilus roxburghii polysaccharose in diabetic mice induced by high-fat diet and streptozotocin. J Ethnopharmacol. 2015 Apr 22;164:180-5. doi: 10.1016/j.jep.2015.01.050. Epub 2015 Feb 7. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans	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.	90 days
Primary	Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans	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.	90 days
Secondary	Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans	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.	90 days
Secondary	Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans	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.	90 days
Secondary	Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile	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.	90 days
Secondary	Renal safety of administration of guazuma, tecoma through the determination of serum creatinine	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.	90 days