Arterial StiffnessNCT04259606
Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus
A study testing Cassia Cinnamon and Calcined magnesia in people with Arterial Stiffness, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Type 2 diabetes mellitus is considered a serious public health problem that has been raising worldwide. In Mexico, it is an important cause of morbi - mortality and it´s characterized by hyperglycemia that promotes an increase of cardiovascular risk through the impairment of arterial stiffness and endothelial… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- Cassia Cinnamon and Calcined magnesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 17 Aug 2018to Sep 2022
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to the beginning of enrollment
- Men and women 40 to 65 years old
- Diagnosis of type 2 diabetes mellitus according to the American Diabetes Association criteria
- Fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L) at least 8 h of fasting
- Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) 2 hours after oral glucose tolerance test
- HbA1c ≥ 6.5 % (48 mmol/mol)
- Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) in a random glucose test with typical symptoms of hyperglucemia or hyperglycemic crisis.
Who cannot join
- HbA1c < 6.5 % or > 10 % or fasting glucose plasma > 250 mg/dl
- Total serum cholesterol ≥ 240 mg/dl
- Triglycerides ≥ 400 mg/dl
- History of allergy to any of the components used in the study
- Consumption of additional drugs with known effects on glucose and lipids metabolism and weight reduction
- History of cardiovascular disease, blood abnormalities and/or kidney, pancreatic or thyroid disease
Show all 10Show fewer
- Childbearing and breastfeeding women
- History of smoking within 12 months prior to beginning of study
- History of drug abuse and alcoholism
- Pacemaker bearing or any other permanent bioelectronic device that could modify or interfere with electrical bioimpedance tests
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, 44340
Sara Pascoe González, PhD, 3331370639, spg0371@gmail.com
María G Ramos Zavala, PhD, 3339523367, ramos.zavala.mg@gmail.com
About this study
Type 2 diabetes mellitus is considered a serious public health problem that has been raising worldwide. In Mexico, it is an important cause of morbi - mortality and it´s characterized by hyperglycemia that promotes an increase of cardiovascular risk through the impairment of arterial stiffness and endothelial function, which, in a chronic manner promotes the development of micro and macrovascular complications.
Many nutraceuticals have been currently implemented aimed to improve glycemic control, and reduce cardiovascular risk and it´s complications, which results in a better quality of life in patients with type 2 diabetes mellitus.
Cassia cinnamon pulverized bark has demonstrated to have vasodilator effect independent of endothelial mechanisms, probably regulating calcium influx or release into or within the cell, the later demonstrated in mice.
Read the detailed description
A randomized, placebo control group, double blind clinical trial. 30 patients (male or female) from 40 to 65 years old with type 2 diabetes mellitus, less than 1 year of diagnosis, taking Metformin 850 mg daily, referred to the Experimental and Clinical Therapeutic Institute will be included.
All patients should give written informed consent prior to be enrolled. The protocol was previously approved by the local ethics committee (Experimental and Clinical Therapeutic Institute) of University of Guadalajara, registration number: CEI/489/2019. Patients with other medical conditions, taking additional drugs or with more than 1 year of evolution will be excluded.
Procedure:
The entire study consists of a total of 5 visits, the first one (day - 7) is the screening visit where written informed consent, clinical history, anthropometric measurements and blood samples will be performed.
The second or initial visit (day 0) consists of review of laboratory results, hemodynamic studies (i.e brachial - ankle pulse wave velocity and index for arterial stiffness and flow mediated dilation on brachial artery for endothelial function with VP1000 and UNEX EF devices respectively), and after randomization, start of intervention (either cassia cinnamon or placebo).
The third and fourth visits (day 30 and 60) consist of evaluation of treatment adherence, side effects, blood tests, treatment renewal and general recommendations.
The fifth and last visit (day 90) is similar to day 0 plus evaluation of treatment adherence and side effects. This is the end of intervention period.
- Conditions
- Arterial Stiffness
- Being tested
- Cassia Cinnamon, Calcined magnesia
- Keywords
- Cassia cinnamon, Endothelial function, Pulse wave velocity, Brachial - ankle index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cassia CinnamonDietary supplement
Reddish - brown to light brown, typical sweet and aromatic free flowing powder.
Calcined magnesiaOther
White, odor, color and flavorless thin powder.
| Study group | Role | What they receive |
|---|---|---|
| Cassia Cinnamon | Active comparator | Cassia cinnamon, capsule of 1 gram each, taken every 8 hours before meals for 90 days. Receives: Dietary Supplement: Cassia Cinnamon |
| Calcined Magnesia | Placebo comparator | Placebo consists in calcined magnesia, capsule of 1 gram each, taken every 8 hours before meals for 90 days. Receives: Other: Calcined magnesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial - ankle pulse wave velocity
Change in the pulse wave velocity
Measured: 90 days
Flow mediated dilation
Change in the capacity of dilation of the brachial artery
Measured: 90 days
Brachial - ankle index
Change in the systolic and diastolic pressures of the brachial and tibial arteries, the index is the result of dividing the last between the first
Measured: 90 days
Secondary outcomes (4)
Systolic and diastolic blood pressure
Millimeters of mercury. mmHg
Measured: 4 visits: days 1, 30, 60 and 90.
Blood glucose
Milligrams over deciliters. mg/dL
Measured: 4 visits: days 1, 30, 60 and 90.
Glycated hemoglobin
Percentage
Measured: 4 visits: days 1, 30, 60 and 90.
Lipid profile
Total cholesterol, triglycerides, high density lipoprotein, very high density lipoprotein, low density lipoprotein. All of them expressed in milligrams over deciliters. mg/dL
Measured: 4 visits: days 1, 30, 60 and 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start17 Aug 2018
- Primary completionJan 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, randomized, double blind, with control group. The study consists in two groups assigned to take either cassia cinnamon or placebo. Both groups will be taken Metformin as first line therapy for type 2 diabetes mellitus
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Pascoe Gonzalez, University of Guadalajara
- Investigators
- Sandra Ofelia Hernández González, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259606
- Sponsor's protocol ID
- CCRA
- Status last verified
- Feb 2020
- First submitted
- 23 Oct 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Diabetes Association. Standards of Medical Care in Diabetes-2019 Abridged for Primary Care Providers. Clin Diabetes. 2019 Jan;37(1):11-34. doi: 10.2337/cd18-0105. No abstract available.
PubMed 30705493Rosas Y, Calles J. Documento de posición de la Asociación Latinoamericana de Diabetes (ALAD). Consenso de prediabetes. 2009;17:146-158
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
PubMed 22922414Arauz A, Ruíz-Franco A. Enfermedad Vascular Cerebral. Rev Fac Medicina UNAM.2012;55:11-21
Ritz E. Nephropathy in type 2 diabetes. J Intern Med. 1999 Feb;245(2):111-26. doi: 10.1046/j.1365-2796.1999.00411.x.
PubMed 10081514Javed S, Alam U, Malik RA. Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):63-83. doi: 10.1900/RDS.2015.12.63. Epub 2015 Aug 10.
PubMed 26676662Pedraza L. Neuropatías diabéticas, formas clínicas y diagnóstico. Rev Med Clin.2009;20:681-686
Julio R, Galleguillos I. Diabetes y enfermedad vascular periférica. Rev Med Clin. 2009;20:687-697
Cervantes R, Presno J. Fisiopatología de la diabetes y los mecanismos de muerte de las células β pancreáticas. Rev. Endocrinol. Nutr.2013;21:98-106
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015 Jan;38(1):140-9. doi: 10.2337/dc14-2441. No abstract available.
PubMed 25538310DeFronzo RA, Abdul-Ghani M. Type 2 diabetes can be prevented with early pharmacological intervention. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S202-9. doi: 10.2337/dc11-s221.
PubMed 21525456de Oliveira Alvim R, Santos PCJL, Musso MM, de Sa Cunha R, Krieger JE, Mill JG, Pereira AC. Impact of diabetes mellitus on arterial stiffness in a representative sample of an urban Brazilian population. Diabetol Metab Syndr. 2013 Aug 21;5(1):45. doi: 10.1186/1758-5996-5-45.
PubMed 23965633Jia G, Aroor AR, DeMarco VG, Martinez-Lemus LA, Meininger GA, Sowers JR. Vascular stiffness in insulin resistance and obesity. Front Physiol. 2015 Aug 14;6:231. doi: 10.3389/fphys.2015.00231. eCollection 2015.
PubMed 26321962Yeboah K, Antwi DA, Gyan B. Arterial Stiffness in Nonhypertensive Type 2 Diabetes Patients in Ghana. Int J Endocrinol. 2016;2016:6107572. doi: 10.1155/2016/6107572. Epub 2016 Sep 28.
PubMed 27774104Li X, Deng YP, Yang M, Wu YW, Sun SX, Sun JZ. Low-Grade Inflammation and Increased Arterial Stiffness in Chinese Youth and Adolescents with Newly-Diagnosed Type 2 Diabetes Mellitus. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):268-73. doi: 10.4274/jcrpe.2187.
PubMed 26777037
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04259606
- Acronym / sponsor ID
- CCRA
- Conditions
- Arterial Stiffness
- Keywords
- Cassia cinnamon, Endothelial function, Pulse wave velocity, Brachial - ankle index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 6 Feb 2020 (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.
Type 2 diabetes mellitus is considered a serious public health problem that has been raising worldwide. In Mexico, it is an important cause of morbi - mortality and it´s characterized by hyperglycemia that promotes an increase of cardiovascular risk through the impairment of arterial stiffness and endothelial function, which, in a chronic manner promotes the development of micro and macrovascular complications.
Many nutraceuticals have been currently implemented aimed to improve glycemic control, and reduce cardiovascular risk and it´s complications, which results in a better quality of life in patients with type 2 diabetes mellitus.
Cassia cinnamon pulverized bark has demonstrated to have vasodilator effect independent of endothelial mechanisms, probably regulating calcium influx or release into or within the cell, the later demonstrated in mice.
Detailed description
A randomized, placebo control group, double blind clinical trial. 30 patients (male or female) from 40 to 65 years old with type 2 diabetes mellitus, less than 1 year of diagnosis, taking Metformin 850 mg daily, referred to the Experimental and Clinical Therapeutic Institute will be included.
All patients should give written informed consent prior to be enrolled. The protocol was previously approved by the local ethics committee (Experimental and Clinical Therapeutic Institute) of University of Guadalajara, registration number: CEI/489/2019. Patients with other medical conditions, taking additional drugs or with more than 1 year of evolution will be excluded.
Procedure:
The entire study consists of a total of 5 visits, the first one (day - 7) is the screening visit where written informed consent, clinical history, anthropometric measurements and blood samples will be performed.
The second or initial visit (day 0) consists of review of laboratory results, hemodynamic studies (i.e brachial - ankle pulse wave velocity and index for arterial stiffness and flow mediated dilation on brachial artery for endothelial function with VP1000 and UNEX EF devices respectively), and after randomization, start of intervention (either cassia cinnamon or placebo).
The third and fourth visits (day 30 and 60) consist of evaluation of treatment adherence, side effects, blood tests, treatment renewal and general recommendations.
The fifth and last visit (day 90) is similar to day 0 plus evaluation of treatment adherence and side effects. This is the end of intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel, randomized, double blind, with control group. The study consists in two groups assigned to take either cassia cinnamon or placebo. Both groups will be taken Metformin as first line therapy for type 2 diabetes mellitus
| Arm | Type | Receives |
|---|---|---|
| Cassia Cinnamon | Active comparator | Dietary Supplement: Cassia CinnamonCassia cinnamon, capsule of 1 gram each, taken every 8 hours before meals for 90 days. |
| Calcined Magnesia | Placebo comparator | Other: Calcined magnesiaPlacebo consists in calcined magnesia, capsule of 1 gram each, taken every 8 hours before meals for 90 days. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent prior to the beginning of enrollment
- Men and women 40 to 65 years old
- Diagnosis of type 2 diabetes mellitus according to the American Diabetes Association criteria
- Fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L) at least 8 h of fasting
- Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) 2 hours after oral glucose tolerance test
Key exclusion criteria (10 listed)
- HbA1c < 6.5 % or > 10 % or fasting glucose plasma > 250 mg/dl
- Total serum cholesterol ≥ 240 mg/dl
- Triglycerides ≥ 400 mg/dl
- History of allergy to any of the components used in the study
- Consumption of additional drugs with known effects on glucose and lipids metabolism and weight reduction
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 |
|---|---|---|
| Cassia CinnamonReddish - brown to light brown, typical sweet and aromatic free flowing powder. | Dietary supplement | Cassia Cinnamon |
| Calcined magnesiaWhite, odor, color and flavorless thin powder. | Other | Calcined Magnesia |
Primary outcome
Brachial - ankle pulse wave velocity
Time frame: 90 days
Change in the pulse wave velocity
Flow mediated dilation
Time frame: 90 days
Change in the capacity of dilation of the brachial artery
Brachial - ankle index
Time frame: 90 days
Change in the systolic and diastolic pressures of the brachial and tibial arteries, the index is the result of dividing the last between the first
4 secondary outcomes
Systolic and diastolic blood pressure
Time frame: 4 visits: days 1, 30, 60 and 90.
Blood glucose
Time frame: 4 visits: days 1, 30, 60 and 90.
Glycated hemoglobin
Time frame: 4 visits: days 1, 30, 60 and 90.
Lipid profile
Time frame: 4 visits: days 1, 30, 60 and 90.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Background: PubMed 30705493American Diabetes Association. Standards of Medical Care in Diabetes-2019 Abridged for Primary Care Providers. Clin Diabetes. 2019 Jan;37(1):11-34. doi: 10.2337/cd18-0105. No abstract available.
- BackgroundRosas Y, Calles J. Documento de posición de la Asociación Latinoamericana de Diabetes (ALAD). Consenso de prediabetes. 2009;17:146-158
- Background: PubMed 22922414Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
- BackgroundArauz A, Ruíz-Franco A. Enfermedad Vascular Cerebral. Rev Fac Medicina UNAM.2012;55:11-21
- Background: PubMed 10081514Ritz E. Nephropathy in type 2 diabetes. J Intern Med. 1999 Feb;245(2):111-26. doi: 10.1046/j.1365-2796.1999.00411.x.
- Background: PubMed 26676662Javed S, Alam U, Malik RA. Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):63-83. doi: 10.1900/RDS.2015.12.63. Epub 2015 Aug 10.
- BackgroundPedraza L. Neuropatías diabéticas, formas clínicas y diagnóstico. Rev Med Clin.2009;20:681-686
- BackgroundJulio R, Galleguillos I. Diabetes y enfermedad vascular periférica. Rev Med Clin. 2009;20:687-697
- BackgroundCervantes R, Presno J. Fisiopatología de la diabetes y los mecanismos de muerte de las células β pancreáticas. Rev. Endocrinol. Nutr.2013;21:98-106
- Background: PubMed 25538310Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015 Jan;38(1):140-9. doi: 10.2337/dc14-2441. No abstract available.
- Background: PubMed 21525456DeFronzo RA, Abdul-Ghani M. Type 2 diabetes can be prevented with early pharmacological intervention. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S202-9. doi: 10.2337/dc11-s221.
- Background: PubMed 23965633de Oliveira Alvim R, Santos PCJL, Musso MM, de Sa Cunha R, Krieger JE, Mill JG, Pereira AC. Impact of diabetes mellitus on arterial stiffness in a representative sample of an urban Brazilian population. Diabetol Metab Syndr. 2013 Aug 21;5(1):45. doi: 10.1186/1758-5996-5-45.
- Chemical properties of bark cinnamon derived CinnamaldehydeLink provided by the sponsor.
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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.
Sandra Ofelia Hernández González, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cassia Cinnamon and Calcined magnesia in people with Arterial Stiffness, run by University of Guadalajara at 1 site in 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Pascoe González, PhD (3331370639, spg0371@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial - ankle pulse wave velocity (time frame: 90 days). The study lists 3 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 NCT04259606, which also lists 57 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 6 Feb 2020.