Metabolic Syndrome XPhase 2NCT02114892
Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
A Phase 2 study testing Resveratrol in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients both sexes
- Age between 30 and 50 years
- Metabolic Syndrome according to the IDF criteria
- Waist circumference
- Man ≥90 cm
- Woman ≥80 cm
Show all 14Show fewer
- And two of the following criteria:
- High density lipoprotein
- Man ≤40 mg/dL
- Woman ≤50 mg/dL
- Fasting glucose ≥100 mg/dL
- Triglycerides ≥150 mg/dL
- Blood pressure ≥130/85 mmHg
- Informed consent signed
Who cannot join
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to resveratrol
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
- Previous treatment for the metabolic syndrome components
Show all 12Show fewer
- Body Mass Index ≥39.9 kg/m2
- Fasting glucose ≥126 mg/dL
- Triglycerides ≥500 mg/dL
- Total cholesterol ≥240 mg/dL
- Low density lipoprotein (c-LDL) ≥190 mg/dL
- Blood Pressure ≥140/90 mmHg
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 45037
About this study
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.
The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.
12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.
The remaining 12 patients received placebo with the same prescription.
Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.
- Conditions
- Metabolic Syndrome X
- Being tested
- Resveratrol, Placebo
- Keywords
- metabolic syndrome, central obesity, resveratrol, insulin secretion, insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called Trans resveratrol, 3, 5, 4' -trihidroxiestilbeno
Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.
PlaceboDrug
Also called Calcined magnesia
Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Resveratrol capsules, 500 mg, three times per day before meals during 90 days Receives: Drug: Resveratrol |
| Placebo | Placebo comparator | Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides Levels at Week 12
The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
Measured: Week 12
High Density Lipoprotein (c-HDL) Levels at Week 12.
The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Measured: Baseline. Week 12
Fasting Glucose Levels at Week 12.
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Measured: Week 12
Systolic Blood Pressure at Week 12.
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
Measured: Week 12
First Phase of Insulin Secretion at Week 12.
The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12
Measured: Week 12
Total Insulin Secretion at Week 12.
The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12
Measured: Week 12
Total Insulin Sensitivity at Week 12.
The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12
Measured: Week 12
Waist Circumference at Week 12
Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12
Measured: Week 12
Diastolic Blood Pressure at Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
Measured: Week 12
Secondary outcomes (6)
Weight at Week 12.
The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Measured: Week 12
Body Mass Index at Week 12
The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
Measured: Week 12
Total Cholesterol at Week 12
The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12
Measured: Week 12
Low Density Lipoproteins (c-LDL) at Week 12
The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12
Measured: Week 12
Creatinine at Week 12.
The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12
Measured: Baseline. Week 12.
Uric Acid at Week 12.
The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12
Measured: Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114892
- Sponsor's protocol ID
- RESV-MS
- Status last verified
- Aug 2020
- First submitted
- 11 Apr 2014
- Last updated
- 17 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beaudeux JL, Nivet-Antoine V, Giral P. Resveratrol: a relevant pharmacological approach for the treatment of metabolic syndrome? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):729-36. doi: 10.1097/MCO.0b013e32833ef291.
PubMed 20823772Szkudelska K, Szkudelski T. Resveratrol, obesity and diabetes. Eur J Pharmacol. 2010 Jun 10;635(1-3):1-8. doi: 10.1016/j.ejphar.2010.02.054. Epub 2010 Mar 19.
PubMed 20303945Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006 Jun;5(6):493-506. doi: 10.1038/nrd2060. Epub 2006 May 26.
PubMed 16732220Timmers S, Auwerx J, Schrauwen P. The journey of resveratrol from yeast to human. Aging (Albany NY). 2012 Mar;4(3):146-58. doi: 10.18632/aging.100445.
PubMed 22436213Kroon PA, Iyer A, Chunduri P, Chan V, Brown L. The Cardiovascular Nutrapharmacology of Resveratrol: Pharmacokinetics, Molecular Mechanisms and Therapeutic Potential. Curr Med Chem. 2010;17(23):2442-55. doi: 10.2174/092986710791556032.
PubMed 20491649Baur JA. Resveratrol, sirtuins, and the promise of a DR mimetic. Mech Ageing Dev. 2010 Apr;131(4):261-9. doi: 10.1016/j.mad.2010.02.007. Epub 2010 Feb 26.
PubMed 20219519Szkudelski T, Szkudelska K. Anti-diabetic effects of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:34-9. doi: 10.1111/j.1749-6632.2010.05844.x.
PubMed 21261639Zhang J. Resveratrol inhibits insulin responses in a SirT1-independent pathway. Biochem J. 2006 Aug 1;397(3):519-27. doi: 10.1042/BJ20050977.
PubMed 16626303Rivera L, Moron R, Zarzuelo A, Galisteo M. Long-term resveratrol administration reduces metabolic disturbances and lowers blood pressure in obese Zucker rats. Biochem Pharmacol. 2009 Mar 15;77(6):1053-63. doi: 10.1016/j.bcp.2008.11.027. Epub 2008 Dec 3.
PubMed 19100718Hung LM, Chen JK, Huang SS, Lee RS, Su MJ. Cardioprotective effect of resveratrol, a natural antioxidant derived from grapes. Cardiovasc Res. 2000 Aug 18;47(3):549-55. doi: 10.1016/s0008-6363(00)00102-4.
PubMed 10963727Yu C, Shin YG, Chow A, Li Y, Kosmeder JW, Lee YS, Hirschelman WH, Pezzuto JM, Mehta RG, van Breemen RB. Human, rat, and mouse metabolism of resveratrol. Pharm Res. 2002 Dec;19(12):1907-14. doi: 10.1023/a:1021414129280.
PubMed 12523673Walle T, Hsieh F, DeLegge MH, Oatis JE Jr, Walle UK. High absorption but very low bioavailability of oral resveratrol in humans. Drug Metab Dispos. 2004 Dec;32(12):1377-82. doi: 10.1124/dmd.104.000885. Epub 2004 Aug 27.
PubMed 15333514Aumont V, Krisa S, Battaglia E, Netter P, Richard T, Merillon JM, Magdalou J, Sabolovic N. Regioselective and stereospecific glucuronidation of trans- and cis-resveratrol in human. Arch Biochem Biophys. 2001 Sep 15;393(2):281-9. doi: 10.1006/abbi.2001.2496.
PubMed 11556815Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health--a comprehensive review of human clinical trials. Mol Nutr Food Res. 2011 Aug;55(8):1129-41. doi: 10.1002/mnfr.201100143. Epub 2011 Jun 20.
PubMed 21688389Baur JA, Pearson KJ, Price NL, Jamieson HA, Lerin C, Kalra A, Prabhu VV, Allard JS, Lopez-Lluch G, Lewis K, Pistell PJ, Poosala S, Becker KG, Boss O, Gwinn D, Wang M, Ramaswamy S, Fishbein KW, Spencer RG, Lakatta EG, Le Couteur D, Shaw RJ, Navas P, Puigserver P, Ingram DK, de Cabo R, Sinclair DA. Resveratrol improves health and survival of mice on a high-calorie diet. Nature. 2006 Nov 16;444(7117):337-42. doi: 10.1038/nature05354. Epub 2006 Nov 1.
PubMed 17086191
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
- ClinicalTrials.gov ID
- NCT02114892
- Acronym / sponsor ID
- RESV-MS
- Conditions
- Metabolic Syndrome X
- Keywords
- metabolic syndrome, central obesity, resveratrol, insulin secretion, insulin sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight.
The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric were evaluated after a 75 g of dextrose load.
12 received resveratrol, 500 mg, three times per day (1500 mg) before meals during 3 months.
The remaining 12 patients received placebo with the same prescription.
Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Drug: ResveratrolResveratrol capsules, 500 mg, three times per day before meals during 90 days |
| Placebo | Placebo comparator | Drug: PlaceboCalcined magnesia capsules, 500 mg, three times per day before meals during 90 days |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients both sexes
- Age between 30 and 50 years
- Metabolic Syndrome according to the IDF criteria
- Waist circumference
- Man ≥90 cm
Key exclusion criteria (12 listed)
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to resveratrol
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
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 |
|---|---|---|
| ResveratrolAlso: Trans resveratrol, 3, 5, 4' -trihidroxiestilbenoResveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. | Drug | Resveratrol |
| PlaceboAlso: Calcined magnesiaCalcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg | Drug | Placebo |
Primary outcome
Triglycerides Levels at Week 12
Time frame: Week 12
The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
High Density Lipoprotein (c-HDL) Levels at Week 12.
Time frame: Baseline. Week 12
The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Fasting Glucose Levels at Week 12.
Time frame: Week 12
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Systolic Blood Pressure at Week 12.
Time frame: Week 12
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
First Phase of Insulin Secretion at Week 12.
Time frame: Week 12
The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12
Total Insulin Secretion at Week 12.
Time frame: Week 12
The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12
Total Insulin Sensitivity at Week 12.
Time frame: Week 12
The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12
Waist Circumference at Week 12
Time frame: Week 12
Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12
Diastolic Blood Pressure at Week 12
Time frame: Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
6 secondary outcomes
Weight at Week 12.
Time frame: Week 12
Body Mass Index at Week 12
Time frame: Week 12
Total Cholesterol at Week 12
Time frame: Week 12
Low Density Lipoproteins (c-LDL) at Week 12
Time frame: Week 12
Creatinine at Week 12.
Time frame: Baseline. Week 12.
Uric Acid at Week 12.
Time frame: Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20823772Beaudeux JL, Nivet-Antoine V, Giral P. Resveratrol: a relevant pharmacological approach for the treatment of metabolic syndrome? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):729-36. doi: 10.1097/MCO.0b013e32833ef291.
- Background: PubMed 20303945Szkudelska K, Szkudelski T. Resveratrol, obesity and diabetes. Eur J Pharmacol. 2010 Jun 10;635(1-3):1-8. doi: 10.1016/j.ejphar.2010.02.054. Epub 2010 Mar 19.
- Background: PubMed 16732220Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006 Jun;5(6):493-506. doi: 10.1038/nrd2060. Epub 2006 May 26.
- Background: PubMed 22436213Timmers S, Auwerx J, Schrauwen P. The journey of resveratrol from yeast to human. Aging (Albany NY). 2012 Mar;4(3):146-58. doi: 10.18632/aging.100445.
- Background: PubMed 20491649Kroon PA, Iyer A, Chunduri P, Chan V, Brown L. The Cardiovascular Nutrapharmacology of Resveratrol: Pharmacokinetics, Molecular Mechanisms and Therapeutic Potential. Curr Med Chem. 2010;17(23):2442-55. doi: 10.2174/092986710791556032.
- Background: PubMed 20219519Baur JA. Resveratrol, sirtuins, and the promise of a DR mimetic. Mech Ageing Dev. 2010 Apr;131(4):261-9. doi: 10.1016/j.mad.2010.02.007. Epub 2010 Feb 26.
- Background: PubMed 21261639Szkudelski T, Szkudelska K. Anti-diabetic effects of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:34-9. doi: 10.1111/j.1749-6632.2010.05844.x.
- Results publication: PubMed 16626303Zhang J. Resveratrol inhibits insulin responses in a SirT1-independent pathway. Biochem J. 2006 Aug 1;397(3):519-27. doi: 10.1042/BJ20050977.
- Results publication: PubMed 19100718Rivera L, Moron R, Zarzuelo A, Galisteo M. Long-term resveratrol administration reduces metabolic disturbances and lowers blood pressure in obese Zucker rats. Biochem Pharmacol. 2009 Mar 15;77(6):1053-63. doi: 10.1016/j.bcp.2008.11.027. Epub 2008 Dec 3.
- Results publication: PubMed 10963727Hung LM, Chen JK, Huang SS, Lee RS, Su MJ. Cardioprotective effect of resveratrol, a natural antioxidant derived from grapes. Cardiovasc Res. 2000 Aug 18;47(3):549-55. doi: 10.1016/s0008-6363(00)00102-4.
- Results publication: PubMed 12523673Yu C, Shin YG, Chow A, Li Y, Kosmeder JW, Lee YS, Hirschelman WH, Pezzuto JM, Mehta RG, van Breemen RB. Human, rat, and mouse metabolism of resveratrol. Pharm Res. 2002 Dec;19(12):1907-14. doi: 10.1023/a:1021414129280.
- Results publication: PubMed 15333514Walle T, Hsieh F, DeLegge MH, Oatis JE Jr, Walle UK. High absorption but very low bioavailability of oral resveratrol in humans. Drug Metab Dispos. 2004 Dec;32(12):1377-82. doi: 10.1124/dmd.104.000885. Epub 2004 Aug 27.
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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.
MANUEL GONZALEZ, 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 Phase 2 study testing Resveratrol in people with Metabolic Syndrome X, 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 14 inclusion and 12 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 17 Sep 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Triglycerides Levels at Week 12 (time frame: Week 12). The study lists 9 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 NCT02114892, which also lists 27 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 17 Sep 2020.