PreDiabetesPhase 4NCT03917784
Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
A Phase 4 study testing Curcumin and Starch in people with PreDiabetes, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
Trial summary
This study evaluates the effects of oral supplementation with curcumin on the insulin sensitivity in subjects with prediabetes. The half of participants will receive curcumin and bioperine in combination, while the other half receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Curcumin and Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteMexico
- Study dates
- 25 Feb 2019to 28 Feb 2020
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women with age between 18 and 60 years old.
- With prediabetes diagnosis, according to the American Diabetes Association :
- Fasting serum glucose: 100-125 mg/dL
- Glycosylated hemoglobin (HbA1c): 5.7-6.4%
- Post-prandial glucose: 140-199 mg/dL after an oral dose of 75 g of glucose.
Who cannot join
- Subjects with any type of diabetes.
- Subjects with body mass index > 35 kg/m2
- Pregnant Women.
- Volunteers who ingest drugs that alter blood glucose levels, antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, fibrates, statins.
- Subjects with serum creatinine > 2 mg/dL or in renal replacement therapy.
- Subjects that normally consume food supplements.
- Subjects with acute infections or with chronical diseases (cancer, rheumatoid arthritis, etc.).
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México Dr. Eduardo Liceaga
Mexico City, Cuauhtémoc, 06720
Ernesto Roldan, 2789-2000 ext. 1164, ernest.roldan@usa.net
About this study
This study evaluates the effects of oral supplementation with curcumin on the insulin sensitivity in subjects with prediabetes. The half of participants will receive curcumin and bioperine in combination, while the other half receive placebo.
Read the detailed description
The therapeutic strategies for prediabetes to this day are based on the change of habits, mainly food and exercise plans. It has been advice, in specific circumstances, to grant a pharmacological regimen.
Curcumin or Curcuma Longa ((1E,6E)21,7-bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione), is the main ingredient of the Hindu condiment, Turmeric, which is obtained from the Rhizome plant. In new studies, it has been documented that the oral consumption of curcumin (Curcuma longa) in pre-diabetic and diabetic patients has a positive effect as an antidiabetic agent thanks to its anti-inflammatory, antioxidant, antithrombotic, cardio and neuroprotective effects. In animal models, it has been shown that oral curcumin consumption is capable of increasing insulin sensitivity in liver, muscle and adipose tissue, increases glucose uptake in muscle and insulin secretion, which is reflected in the reduction of hyperglycemia, glycosylated hemoglobin, decrease of the homeostatic model assessment of insulin resistance (HOMA-IR) and decrease of serum lipids.
Curcumin has been included in the oriental diet since ancient times and is used in traditional medicine, which is why it is considered safe, since its consumption is approved by the FDA (Federal Drugs Administration). A 12g per day dose has shown no side effects in humans. Therefore, it is proposed that the consumption of curcumin in pre-diabetic patients can improve glucose tolerance and decrease insulin resistance parameters.
- Conditions
- PreDiabetes
- Being tested
- Curcumin, Starch
- Keywords
- Curcumin, Insulin sensitivity, HOMA
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Oral supplementation with curcumin 500 mg oral dosing for 3 months
StarchDrug
Oral supplementation with starch 500 mg oral dosing for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Curcumin and bioperine | Experimental | This group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months Receives: Drug: Curcumin |
| Placebo | Placebo comparator | This group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months Receives: Drug: Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA- IR
(Insulin µU/ml)(Glucose mg/dl)/405.
Measured: 3 months
HOMA- Beta
(20)(FPI)/(FPG - 3.5)
Measured: 3 months
Matsuda index
10,000/√[(basal glucose)(basal insulin)*(glucose)(insulin)]
Measured: 3 months
Secondary outcomes (17)
weight
weight in kilograms
Measured: 6 weeks and 12 weeks
height
height in centimetres
Measured: 6 weeks and 12 weeks
waist circumference
waist circumference in centimetres
Measured: 6 weeks and 12 weeks
hip circumference.
hip circumference in centimetres
Measured: 6 weeks and 12 weeks
insulin
insulin in µU/ml
Measured: 6 weeks and 12 weeks
triglycerides
triglycerides in mg/dl
Measured: 6 weeks and 12 weeks
cholesterol
cholesterol in mg/dl
Measured: 6 weeks and 12 weeks
HDL cholesterol
HDL cholesterol in mg/dl
Measured: 6 weeks and 12 weeks
LDL cholesterol
LDL cholesterol in mg/dl
Measured: 6 weeks and 12 weeks
uric acid
uric acid in mg/dl
Measured: 6 weeks and 12 weeks
creatinine
creatinine in mg/dl
Measured: 6 weeks and 12 weeks
urea
urea in mg/dl
Measured: 6 weeks and 12 weeks
alanine amino transferase
alanine amino transferase in U/L
Measured: 6 weeks and 12 weeks
alkaline phosphatase
alkaline phosphatase in U/L
Measured: 6 weeks and 12 weeks
lactic dehydrogenase
lactic dehydrogenase in U/L
Measured: 6 weeks and 12 weeks
glycosylated hemoglobin
glycosylated hemoglobin in percentage
Measured: 6 weeks and 12 weeks
total bilirubin
total bilirubin in mg/dl
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start25 Feb 2019
- Primary completion30 Nov 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, César Leonardo González Aguilar, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917784
- Sponsor's protocol ID
- DI/18/111/03/067
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identified individual participant data for all primary and secondary outcomes measures will be made avaliable
Publications
American Diabetes Association. 5. Prevention or Delay of Type 2 Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S51-S54. doi: 10.2337/dc18-S005.
PubMed 29222376American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi: 10.2337/dc18-S002.
PubMed 29222373Alibasic E, Ramic E, Alic A. Prevention of diabetes in family medicine. Mater Sociomed. 2013;25(2):80-2. doi: 10.5455/msm.2013.25.80-82.
PubMed 24082827Ferrannini E. Definition of intervention points in prediabetes. Lancet Diabetes Endocrinol. 2014 Aug;2(8):667-75. doi: 10.1016/S2213-8587(13)70175-X. Epub 2014 Jan 28.
PubMed 24731662Rojas-Martinez R, Basto-Abreu A, Aguilar-Salinas CA, Zarate-Rojas E, Villalpando S, Barrientos-Gutierrez T. [Prevalence of previously diagnosed diabetes mellitus in Mexico.]. Salud Publica Mex. 2018 May-Jun;60(3):224-232. doi: 10.21149/8566. Spanish.
PubMed 29746739Defronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, Gastaldelli A; ACT NOW Study. Prediction of diabetes based on baseline metabolic characteristics in individuals at high risk. Diabetes Care. 2013 Nov;36(11):3607-12. doi: 10.2337/dc13-0520. Epub 2013 Sep 23.
PubMed 24062330Abdul-Ghani MA, Abdul-Ghani T, Stern MP, Karavic J, Tuomi T, Bo I, Defronzo RA, Groop L. Two-step approach for the prediction of future type 2 diabetes risk. Diabetes Care. 2011 Sep;34(9):2108-12. doi: 10.2337/dc10-2201. Epub 2011 Jul 25.
PubMed 21788628Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC; ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014 Jul-Aug;28(4):553-8. doi: 10.1016/j.jdiacomp.2014.02.012. Epub 2014 Mar 2.
PubMed 24684774Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
PubMed 3899825Bonora E, Targher G, Alberiche M, Bonadonna RC, Saggiani F, Zenere MB, Monauni T, Muggeo M. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studies in subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care. 2000 Jan;23(1):57-63. doi: 10.2337/diacare.23.1.57.
PubMed 10857969Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
PubMed 10480510Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6.
PubMed 22773702Na LX, Li Y, Pan HZ, Zhou XL, Sun DJ, Meng M, Li XX, Sun CH. Curcuminoids exert glucose-lowering effect in type 2 diabetes by decreasing serum free fatty acids: a double-blind, placebo-controlled trial. Mol Nutr Food Res. 2013 Sep;57(9):1569-77. doi: 10.1002/mnfr.201200131. Epub 2012 Aug 29.
PubMed 22930403Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 6.
PubMed 24445038Zhao SG, Li Q, Liu ZX, Wang JJ, Wang XX, Qin M, Wen QS. Curcumin attenuates insulin resistance in hepatocytes by inducing Nrf2 nuclear translocation. Hepatogastroenterology. 2011 Nov-Dec;58(112):2106-11. doi: 10.5754/hge11219.
PubMed 22024084
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Supplementation With Curcumin on Insulin Sensitivity in Subjects With Prediabetes
- ClinicalTrials.gov ID
- NCT03917784
- Acronym / sponsor ID
- DI/18/111/03/067
- Conditions
- PreDiabetes
- Keywords
- Curcumin, Insulin sensitivity, HOMA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 17 Apr 2019 (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.
This study evaluates the effects of oral supplementation with curcumin on the insulin sensitivity in subjects with prediabetes. The half of participants will receive curcumin and bioperine in combination, while the other half receive placebo.
Detailed description
The therapeutic strategies for prediabetes to this day are based on the change of habits, mainly food and exercise plans. It has been advice, in specific circumstances, to grant a pharmacological regimen.
Curcumin or Curcuma Longa ((1E,6E)21,7-bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione), is the main ingredient of the Hindu condiment, Turmeric, which is obtained from the Rhizome plant. In new studies, it has been documented that the oral consumption of curcumin (Curcuma longa) in pre-diabetic and diabetic patients has a positive effect as an antidiabetic agent thanks to its anti-inflammatory, antioxidant, antithrombotic, cardio and neuroprotective effects. In animal models, it has been shown that oral curcumin consumption is capable of increasing insulin sensitivity in liver, muscle and adipose tissue, increases glucose uptake in muscle and insulin secretion, which is reflected in the reduction of hyperglycemia, glycosylated hemoglobin, decrease of the homeostatic model assessment of insulin resistance (HOMA-IR) and decrease of serum lipids.
Curcumin has been included in the oriental diet since ancient times and is used in traditional medicine, which is why it is considered safe, since its consumption is approved by the FDA (Federal Drugs Administration). A 12g per day dose has shown no side effects in humans. Therefore, it is proposed that the consumption of curcumin in pre-diabetic patients can improve glucose tolerance and decrease insulin resistance parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Curcumin and bioperine | Experimental | Drug: CurcuminThis group will receive curcumin 500 mg and bioperine 5 mg oral dosing every 12 hours for 3 months |
| Placebo | Placebo comparator | Drug: StarchThis group will receive placebo (starch) 500 mg oral dosing every 12 hours for 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women with age between 18 and 60 years old.
- With prediabetes diagnosis, according to the American Diabetes Association :
Key exclusion criteria (7 listed)
- Subjects with any type of diabetes.
- Subjects with body mass index > 35 kg/m2
- Pregnant Women.
- Volunteers who ingest drugs that alter blood glucose levels, antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, fibrates, statins.
- Subjects with serum creatinine > 2 mg/dL or in renal replacement therapy.
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 |
|---|---|---|
| CurcuminOral supplementation with curcumin 500 mg oral dosing for 3 months | Drug | Curcumin and bioperine |
| StarchOral supplementation with starch 500 mg oral dosing for 3 months | Drug | Placebo |
Primary outcome
HOMA- IR
Time frame: 3 months
(Insulin µU/ml)(Glucose mg/dl)/405.
HOMA- Beta
Time frame: 3 months
(20)(FPI)/(FPG - 3.5)
Matsuda index
Time frame: 3 months
10,000/√[(basal glucose)(basal insulin)*(glucose)(insulin)]
17 secondary outcomes
weight
Time frame: 6 weeks and 12 weeks
height
Time frame: 6 weeks and 12 weeks
waist circumference
Time frame: 6 weeks and 12 weeks
hip circumference.
Time frame: 6 weeks and 12 weeks
insulin
Time frame: 6 weeks and 12 weeks
triglycerides
Time frame: 6 weeks and 12 weeks
cholesterol
Time frame: 6 weeks and 12 weeks
HDL cholesterol
Time frame: 6 weeks and 12 weeks
LDL cholesterol
Time frame: 6 weeks and 12 weeks
uric acid
Time frame: 6 weeks and 12 weeks
creatinine
Time frame: 6 weeks and 12 weeks
urea
Time frame: 6 weeks and 12 weeks
alanine amino transferase
Time frame: 6 weeks and 12 weeks
alkaline phosphatase
Time frame: 6 weeks and 12 weeks
lactic dehydrogenase
Time frame: 6 weeks and 12 weeks
glycosylated hemoglobin
Time frame: 6 weeks and 12 weeks
total bilirubin
Time frame: 6 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 29222376American Diabetes Association. 5. Prevention or Delay of Type 2 Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S51-S54. doi: 10.2337/dc18-S005.
- Background: PubMed 29222373American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi: 10.2337/dc18-S002.
- Background: PubMed 24082827Alibasic E, Ramic E, Alic A. Prevention of diabetes in family medicine. Mater Sociomed. 2013;25(2):80-2. doi: 10.5455/msm.2013.25.80-82.
- Background: PubMed 24731662Ferrannini E. Definition of intervention points in prediabetes. Lancet Diabetes Endocrinol. 2014 Aug;2(8):667-75. doi: 10.1016/S2213-8587(13)70175-X. Epub 2014 Jan 28.
- Results publication: PubMed 29746739Rojas-Martinez R, Basto-Abreu A, Aguilar-Salinas CA, Zarate-Rojas E, Villalpando S, Barrientos-Gutierrez T. [Prevalence of previously diagnosed diabetes mellitus in Mexico.]. Salud Publica Mex. 2018 May-Jun;60(3):224-232. doi: 10.21149/8566. Spanish.
- Results publication: PubMed 24062330Defronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, Gastaldelli A; ACT NOW Study. Prediction of diabetes based on baseline metabolic characteristics in individuals at high risk. Diabetes Care. 2013 Nov;36(11):3607-12. doi: 10.2337/dc13-0520. Epub 2013 Sep 23.
- Results publication: PubMed 21788628Abdul-Ghani MA, Abdul-Ghani T, Stern MP, Karavic J, Tuomi T, Bo I, Defronzo RA, Groop L. Two-step approach for the prediction of future type 2 diabetes risk. Diabetes Care. 2011 Sep;34(9):2108-12. doi: 10.2337/dc10-2201. Epub 2011 Jul 25.
- Results publication: PubMed 24684774Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC; ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014 Jul-Aug;28(4):553-8. doi: 10.1016/j.jdiacomp.2014.02.012. Epub 2014 Mar 2.
- Results publication: PubMed 3899825Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
- Results publication: PubMed 10857969Bonora E, Targher G, Alberiche M, Bonadonna RC, Saggiani F, Zenere MB, Monauni T, Muggeo M. Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: studies in subjects with various degrees of glucose tolerance and insulin sensitivity. Diabetes Care. 2000 Jan;23(1):57-63. doi: 10.2337/diacare.23.1.57.
- Results publication: PubMed 10480510Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
- Results publication: PubMed 22773702Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6.
- Individual participant dataSharing planned: Yes. Identified individual participant data for all primary and secondary outcomes measures will be made avaliable
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curcumin and Starch in people with PreDiabetes, run by Hospital General de México Dr. Eduardo Liceaga 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 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 César L González (01 993 117 1322, celsbca_21033@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA- IR (time frame: 3 months). 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 NCT03917784, which also lists 25 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 Apr 2019.