Type 2 Diabetes MellitusPhase 2/3GUATECONCT03313856
Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
A Phase 2/3 study testing Guazuma Ulmifolia plus Tecoma Stans and Calcinaned magnesia in people with Type 2 Diabetes Mellitus, run by Centro Universitario de Ciencias de la Salud, Mexico.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Guazuma Ulmifolia plus Tecoma Stans and Calcinaned magnesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2010to 31 May 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Guazuma Ulmifolia plus Tecoma Stans, Calcinaned magnesia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guazuma Ulmifolia plus Tecoma StansDrug
Also called GUATECO
Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
Calcinaned magnesiaDrug
Also called Placebo
Calcined magnesia 400 mg per capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days. Receives: Drug: Calcinaned magnesia |
| Guazuma ulmifolia plus Tecoma stans | Experimental | 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. Receives: Drug: Guazuma Ulmifolia plus Tecoma Stans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
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.
Measured: 90 days
Secondary outcomes (4)
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start10 Jan 2010
- Primary completion31 Dec 2010
- Study completion31 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups were formed that were randomly assigned with the closed envelope technique to the corresponding group. Group Placebo vs. Guazuma ulmifolia plusTecoma stans
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Guadalupe Ramos Zavala, Centro Universitario de Ciencias de la Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313856
- Sponsor's protocol ID
- 1111
- Acronym
- GUATECO
- Status last verified
- Oct 2017
- First submitted
- 27 Sep 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. No abstract available.
PubMed 22087686Saisho Y. beta-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.
PubMed 25685282Andrade-Cetto A, Heinrich M. Mexican plants with hypoglycaemic effect used in the treatment of diabetes. J Ethnopharmacol. 2005 Jul 14;99(3):325-48. doi: 10.1016/j.jep.2005.04.019.
PubMed 15964161Frei 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. doi: 10.1016/s0378-8741(98)00051-8.
PubMed 9741887Leonti M, Sticher O, Heinrich M. Medicinal plants of the Popoluca, Mexico: organoleptic properties as indigenous selection criteria. J Ethnopharmacol. 2002 Aug;81(3):307-15. doi: 10.1016/s0378-8741(02)00078-8.
PubMed 12127230Roman-Ramos R, Flores-Saenz JL, Partida-Hernandez G, Lara-Lemus A, Alarcon-Aguilar F. Experimental study of the hypoglycemic effect of some antidiabetic plants. Arch Invest Med (Mex). 1991 Jan-Mar;22(1):87-93.
PubMed 1819981Alonso-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.
PubMed 18487028Cano JH, Volpato G. Herbal mixtures in the traditional medicine of eastern Cuba. J Ethnopharmacol. 2004 Feb;90(2-3):293-316. doi: 10.1016/j.jep.2003.10.012.
PubMed 15013195Alarcon-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. doi: 10.1016/s0378-8741(98)00020-8.
PubMed 9683340Eddouks 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.
PubMed 24730446Zhang 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.
PubMed 25660333Tukappa 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(1):19. doi: 10.1186/s40659-015-0009-8.
PubMed 25857314Wang 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.
PubMed 24974464Pascoe-Gonzalez S, Ramos-Zavala MG, Buenrostro Ahued MA, Hernandez-Gonzalez SO, Cardona-Munoz EG, Garcia-Benavides L, Grover-Paez F. Administration of Herbarium Mixture (Guazuma ulmifolia/Tecoma stans) on Metabolic Profile in Type 2 Diabetes Mellitus Patients: A Randomized, Double-Blind, Placebo-Controlled Trial. J Med Food. 2021 May;24(5):527-532. doi: 10.1089/jmf.2020.0082. Epub 2020 Sep 21.
PubMed 32955964
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03313856
- Acronym / sponsor ID
- GUATECO / 1111
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 10 Jan 2010 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 May 2011 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two study groups were formed that were randomly assigned with the closed envelope technique to the corresponding group. Group Placebo vs. Guazuma ulmifolia plusTecoma stans
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Calcinaned magnesiaThe patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days. |
| Guazuma ulmifolia plus Tecoma stans | Experimental | Drug: Guazuma Ulmifolia plus Tecoma StansThe patients were randomly assigned to received the herbarium mixture (GU/TS) , 1 capsule of 400mg, before each meal for a period of 90 days. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guazuma Ulmifolia plus Tecoma StansAlso: GUATECOGuazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule | Drug | Guazuma ulmifolia plus Tecoma stans |
| Calcinaned magnesiaAlso: PlaceboCalcined magnesia 400 mg per capsule | Drug | Placebo |
Primary outcome
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.
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.
4 secondary outcomes
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
Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
Time frame: 90 days
Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile
Time frame: 90 days
Renal safety of administration of guazuma, tecoma through the determination of serum creatinine
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Background: PubMed 22087686Kaufman RJ. Beta-cell failure, stress, and type 2 diabetes. N Engl J Med. 2011 Nov 17;365(20):1931-3. doi: 10.1056/NEJMcibr1109442. No abstract available.
- Background: PubMed 25685282Saisho Y. beta-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.
- Background: PubMed 15964161Andrade-Cetto A, Heinrich M. Mexican plants with hypoglycaemic effect used in the treatment of diabetes. J Ethnopharmacol. 2005 Jul 14;99(3):325-48. doi: 10.1016/j.jep.2005.04.019.
- Background: PubMed 9741887Frei 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. doi: 10.1016/s0378-8741(98)00051-8.
- Background: PubMed 12127230Leonti M, Sticher O, Heinrich M. Medicinal plants of the Popoluca, Mexico: organoleptic properties as indigenous selection criteria. J Ethnopharmacol. 2002 Aug;81(3):307-15. doi: 10.1016/s0378-8741(02)00078-8.
- Background: PubMed 1819981Roman-Ramos R, Flores-Saenz JL, Partida-Hernandez G, Lara-Lemus A, Alarcon-Aguilar F. Experimental study of the hypoglycemic effect of some antidiabetic plants. Arch Invest Med (Mex). 1991 Jan-Mar;22(1):87-93.
- Background: PubMed 18487028Alonso-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.
- Background: PubMed 15013195Cano JH, Volpato G. Herbal mixtures in the traditional medicine of eastern Cuba. J Ethnopharmacol. 2004 Feb;90(2-3):293-316. doi: 10.1016/j.jep.2003.10.012.
- Background: PubMed 9683340Alarcon-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. doi: 10.1016/s0378-8741(98)00020-8.
- Background: PubMed 24730446Eddouks 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.
- Background: PubMed 25660333Zhang 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.
- Background: PubMed 25857314Tukappa 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(1):19. doi: 10.1186/s40659-015-0009-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Guazuma Ulmifolia plus Tecoma Stans and Calcinaned magnesia in people with Type 2 Diabetes Mellitus, run by Centro Universitario de Ciencias de la Salud, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313856, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.