PreDiabetesPhase 2NCT03848533
Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes
A Phase 2 study testing melatonin and metformin in people with PreDiabetes, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. Patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction of reactive oxygen species caused by levels of hyperglycemia that generate DNA modification in pancreatic beta cells… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- melatonin and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 22 Aug 2019to Dec 2021
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age beween 30 to 60 years old.
- Diagnosis of Prediabetes state according to the American Diabetes Association criteria.
- Without pharmacological treatment.
- Body mass index between 25 to 34.9 Kg/m2
- Sign informed consent
Who cannot join
- Patients with pharmacological treatment.
- Pregnant woman
- Patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment
- Workers on night or changing shifts.
- Subjects that have been exposed to radiation
- Dyslipidemia: Total cholesterol >250mg/dL, Triglycerides >500 mg/dL.
Show all 9Show fewer
- Subjects that have travel to other place with a different time zone.
- Patients with diagnosis of insomnia
- Patients with a glomerular filtration <60 ml/min using the Cockroft-Gault Formula.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
Lizet Yadira Rosales-Rivera, PhD Science, 52+ (33) 1058-5200 ext. 34211, lizet.rosales@gmail.com
Esperanza Martínez, PhD Science, 52+(33) 1058-5200 ext. 34211, esperanzamartnezabundi@yahoo.com
About this study
Official title: Effect of the Administration of Melatonin and Metformin on Glycemic Control, Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes: Pilot Study
Melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. Patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction of reactive oxygen species caused by levels of hyperglycemia that generate DNA modification in pancreatic beta cells, which leads to apoptosis and a deficient production of insulin. The administration of metformin and melatonin could be a possibility to treat and reverse the prediabetic state decreasing the glycemic levels and reactive oxygen species production.
Read the detailed description
A randomized, double blind, placebo-controlled, pilot clinical trial will carried out in 42 patients with a diagnosis of prediabetes, according to the American Diabetes Association criteria. The patients will be divide in three groups administrating metformin plus placebo, melatonin plus placebo or melatonin plus metformin. The intervention will be with 500 mg lengthed release tablets of metformin once a day in the morning, per 90 days, 5 mg lengthed release capsules of melatonin one a day in the night per 90 days and calcined magnesia as a placebo. Before and after the intervention, will be evaluate: fasting plasma glucose, blood glucose after an oral glucose tolerance test, A1c hemoglobin fraction, micronuclei frequency, nuclear anomalies frequency, insulin secretion and insulin sensitivity, weight, height, body mass index, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, creatinine, uric acid, and sleep quality.
- Conditions
- PreDiabetes
- Keywords
- Melatonin, Metformin, Pre Diabetes, PreDiabetes, Micronuclei, Genotoxicity Markers, Cytotoxicity Markers
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
Also called Cronocaps
The administration of melatonin will be indicated at night before bedtime to avoid alterations of the circadian cycle. It will be contained in bottles labeled "Medication 2" to maintain the masking. This intervention will be indicated in two groups (Melatonin plus metformin and Melatonin plus placebo)
metforminDrug
Also called Ifor
For the intervention with metformin, prolonged-release tablets will be used to reduce adverse effects and improve adherence to treatment. It will be contained in bottles labeled "Medication 1" to maintain masking. This intervention will be indicated in two groups (Melatonin plus metformin and metformin plus placebo)
PlaceboDrug
Also called Calcined magnesia
The placebo may be contained in bottles labeled "Medication 1" or "Medication 2" depending on the time of administration, and the group in which it is used. Placebo will be used in two groups (Melatonin plus placebo and Metformin plus placebo)
| Study group | Role | What they receive |
|---|---|---|
| melatonin plus metformin | Experimental | It will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days.
Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before bedtime) per 90 days. Receives: Drug: melatonin; Drug: metformin |
| metformin plus placebo | Active comparator | It will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days.
Will administrate homologated placebo once a day in the night (before bedtime) per 90 days. Receives: Drug: metformin; Drug: Placebo |
| melatonin plus placebo | Experimental | It will be indicate homologated placebo once a day in the morning (before breakfast) per 90 days.
Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before sleep) per 90 days. Receives: Drug: melatonin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose (FPG)
The FPG will be evaluate in a blood sample after a 8 - 12 hour fasting period. Will be use a fotometric quantification of glucose levels in plasma sample and will report in mg/dL.
Measured: Baseline to week 12
Blood Glucose level after an Oral Glucose tolerance Test
Will estimate the glucose levels at 2 hours after administration of 75 grams of anhydrid dextrosa. The result will report in mg/dL.
Measured: Baseline to week 12
A1c Hemoglobin Fraction (HbA1C)
HbA1c will be measured with High-performance liquid chromatography technique from a blood sample. The result will report in percentage (%).
Measured: Baseline to week 12
Micronuclei frequency
The frequency of micronuclei will be measured from a cytological sample obtained from the oral epithelium by careful scraping of both cheeks. A fluorescence technique will be performed using acridine orange, as well as a Giemsa-Wrigth stain. The result will be reported in micronucleus frequency per 1000 cells.
Measured: Baseline to week 12
Nuclear anomalies frequency
The nuclear anomalies frequency will be measured from a cytological sample obtained from the oral epithelium by careful scraping of both cheeks. A fluorescence technique will be performed using acridine orange, as well as a Giemsa-Wrigth stain. They will be divided according to their morphology (multinucleated cells, pyknotic nucleus, karyorrhexis, caryolysis, nuclei buds, condensed chromatin) and will be reported by the number of findings per 1000 cells.
Measured: Baseline to week 12
Secondary outcomes (11)
Body height
It will be determined using the electric bioimpedance scale with electrical stadiometer. The measurement will be made with the patient standing on the marks on the bioimpedance scale, in an upright position. This determination will be reported in meters (m) with a minimum precision of 0.01 meters.
Measured: Baseline to week 12
Body weight
t will be determined using the electric bioimpedance scale with electrical stadiometer. The measurement will be made with the patient standing on the marks on the bioimpedance scale, in an upright position. This determination will be reported in kilograms (Kg).
Measured: Baseline to week 12
Body mass index
The calculation will be made using the results of the weight, and height. From these results will be calculated by dividing the weight obtained over the square of the height. This index will be reported in kilograms per square meter (kg / m2)
Measured: Baseline to week 12
Insulin Secretion
The calculation will be made using the insulogenic index, using the values obtained in the oral glucose tolerance test, and determining the insulin levels in plasma at 120 minutes and at the baseline measurement, as well as the glucose levels obtained at the 120 minutes and at the baseline measurement.
Measured: Baseline to week 12
Baseline Insulin Secretion
It will be use the Stumvoll index for the calculation of this parameter.
Measured: Baseline to week 12
Insulin sensitivity
For the calculation of this parameter the Matsuda index will be used, from the values obtained and applying the formula.
Measured: Baseline to week 12
Total Cholesterol
The determination of total cholesterol will be made from a blood sample with the patient fasting between 8 to 12 hours. Samples will be analyzed by spectrophotometry. The result will be reported in milligrams per deciliter (mg / dL).
Measured: Baseline to week 12
High-density lipoprotein (HDL)
The determination of HDL will be made from a blood sample with the patient fasting between 8 to 12 hours. Samples will be analyzed by spectrophotometry. The result will be reported in milligrams per deciliter (mg / dL).
Measured: Baseline to week 12
Low-density lipoprotein
LDL will be calculated using the Friedewald formula from the results obtained of total cholesterol, HDL and triglycerides. The result will be expressed in milligrams per deciliter (mg / dl).
Measured: Baseline to week 12
Triglycerides
The determination of triglycerides will be made from a blood sample with the patient fasting between 8 to 12 hours. Samples will be analyzed by spectrophotometry. The result will be reported in milligrams per deciliter (mg / dL).
Measured: Baseline to week 12
Serum Lactate
The determination of serum lactate will be made from a blood sample with the patient fasting between 8 to 12 hours. Samples will be analyzed by spectrophotometry. The result will be reported in millimoles per Liter (mg / dL).
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start22 Aug 2019
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lizet Yadira Rosales Rivera, University of Guadalajara
- Investigators
- Lizet Yadira Rosales-Rivera, PhD Science, Principal investigator, Instituto de terapeutica experimental y clínica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848533
- Sponsor's protocol ID
- CT-MEL-LESM
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American 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 29222373Brannick B, Wynn A, Dagogo-Jack S. Prediabetes as a toxic environment for the initiation of microvascular and macrovascular complications. Exp Biol Med (Maywood). 2016 Jun;241(12):1323-31. doi: 10.1177/1535370216654227.
PubMed 27302176Ferrannini E, Gastaldelli A, Iozzo P. Pathophysiology of prediabetes. Med Clin North Am. 2011 Mar;95(2):327-39, vii-viii. doi: 10.1016/j.mcna.2010.11.005.
PubMed 21281836Wilson ML. Prediabetes: Beyond the Borderline. Nurs Clin North Am. 2017 Dec;52(4):665-677. doi: 10.1016/j.cnur.2017.07.011. Epub 2017 Oct 5.
PubMed 29080583Hostalek U, Gwilt M, Hildemann S. Therapeutic Use of Metformin in Prediabetes and Diabetes Prevention. Drugs. 2015 Jul;75(10):1071-94. doi: 10.1007/s40265-015-0416-8.
PubMed 26059289Serrano R, Garcia-Soidan FJ, Diaz-Redondo A, Artola S, Franch J, Diez J, Carrillo L, Ezkurra P, Millaruelo JM, Segui M, Sangros FJ, Martinez-Candela J, Munoz P, Goday A, Regidor E; Grupo de Estudio PREDADS. Cohort Study in Primary Health Care on the Evolution of Patients with Prediabetes (PREDAPS): basis and methodology. Rev Esp Salud Publica. 2013 Mar-Apr;87(2):121-35. doi: 10.4321/S1135-57272013000200003. English, Spanish.
PubMed 23775102Yang H, Jin X, Kei Lam CW, Yan SK. Oxidative stress and diabetes mellitus. Clin Chem Lab Med. 2011 Nov;49(11):1773-82. doi: 10.1515/CCLM.2011.250. Epub 2011 Aug 3.
PubMed 21810068Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.
PubMed 21030723Tang WH, Martin KA, Hwa J. Aldose reductase, oxidative stress, and diabetic mellitus. Front Pharmacol. 2012 May 9;3:87. doi: 10.3389/fphar.2012.00087. eCollection 2012.
PubMed 22582044Rolo AP, Palmeira CM. Diabetes and mitochondrial function: role of hyperglycemia and oxidative stress. Toxicol Appl Pharmacol. 2006 Apr 15;212(2):167-78. doi: 10.1016/j.taap.2006.01.003. Epub 2006 Feb 20.
PubMed 16490224Brownlee M. Biochemistry and molecular cell biology of diabetic complications. Nature. 2001 Dec 13;414(6865):813-20. doi: 10.1038/414813a.
PubMed 11742414Torres-Bugarin O, Zavala-Cerna MG, Nava A, Flores-Garcia A, Ramos-Ibarra ML. Potential uses, limitations, and basic procedures of micronuclei and nuclear abnormalities in buccal cells. Dis Markers. 2014;2014:956835. doi: 10.1155/2014/956835. Epub 2014 Feb 4.
PubMed 24778463Jdey W, Thierry S, Popova T, Stern MH, Dutreix M. Micronuclei Frequency in Tumors Is a Predictive Biomarker for Genetic Instability and Sensitivity to the DNA Repair Inhibitor AsiDNA. Cancer Res. 2017 Aug 15;77(16):4207-4216. doi: 10.1158/0008-5472.CAN-16-2693. Epub 2017 Jun 6.
PubMed 28588010Kisurina-Evgenieva OP, Sutiagina OI, Onishchenko GE. Biogenesis of Micronuclei. Biochemistry (Mosc). 2016 May;81(5):453-64. doi: 10.1134/S0006297916050035.
PubMed 27297896Graham GG, Punt J, Arora M, Day RO, Doogue MP, Duong JK, Furlong TJ, Greenfield JR, Greenup LC, Kirkpatrick CM, Ray JE, Timmins P, Williams KM. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011 Feb;50(2):81-98. doi: 10.2165/11534750-000000000-00000.
PubMed 21241070
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Melatonin and Metformin on Glycemic Control, Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes: Pilot Study
- ClinicalTrials.gov ID
- NCT03848533
- Acronym / sponsor ID
- CT-MEL-LESM
- Conditions
- PreDiabetes
- Keywords
- Melatonin, Metformin, Pre Diabetes, PreDiabetes, Micronuclei, Genotoxicity Markers, Cytotoxicity Markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Feb 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.
Melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. Patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction of reactive oxygen species caused by levels of hyperglycemia that generate DNA modification in pancreatic beta cells, which leads to apoptosis and a deficient production of insulin. The administration of metformin and melatonin could be a possibility to treat and reverse the prediabetic state decreasing the glycemic levels and reactive oxygen species production.
Detailed description
A randomized, double blind, placebo-controlled, pilot clinical trial will carried out in 42 patients with a diagnosis of prediabetes, according to the American Diabetes Association criteria. The patients will be divide in three groups administrating metformin plus placebo, melatonin plus placebo or melatonin plus metformin. The intervention will be with 500 mg lengthed release tablets of metformin once a day in the morning, per 90 days, 5 mg lengthed release capsules of melatonin one a day in the night per 90 days and calcined magnesia as a placebo. Before and after the intervention, will be evaluate: fasting plasma glucose, blood glucose after an oral glucose tolerance test, A1c hemoglobin fraction, micronuclei frequency, nuclear anomalies frequency, insulin secretion and insulin sensitivity, weight, height, body mass index, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, creatinine, uric acid, and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| melatonin plus metformin | Experimental | Drug: melatonin, Drug: metforminIt will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days. Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before bedtime) per 90 days. |
| metformin plus placebo | Active comparator | Drug: metformin, Drug: PlaceboIt will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days. Will administrate homologated placebo once a day in the night (before bedtime) per 90 days. |
| melatonin plus placebo | Experimental | Drug: melatonin, Drug: PlaceboIt will be indicate homologated placebo once a day in the morning (before breakfast) per 90 days. Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before sleep) per 90 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age beween 30 to 60 years old.
- Diagnosis of Prediabetes state according to the American Diabetes Association criteria.
- Without pharmacological treatment.
- Body mass index between 25 to 34.9 Kg/m2
- Sign informed consent
Key exclusion criteria (9 listed)
- Patients with pharmacological treatment.
- Pregnant woman
- Patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment
- Workers on night or changing shifts.
- Subjects that have been exposed to radiation
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 |
|---|---|---|
| melatoninAlso: CronocapsThe administration of melatonin will be indicated at night before bedtime to avoid alterations of the circadian cycle. It will be contained in bottles labeled "Medication 2" to maintain the masking. This intervention will be indicated in two groups (Melatonin plus metformin and Melatonin plus placebo) | Drug | melatonin plus metformin, melatonin plus placebo |
| metforminAlso: IforFor the intervention with metformin, prolonged-release tablets will be used to reduce adverse effects and improve adherence to treatment. It will be contained in bottles labeled "Medication 1" to maintain masking. This intervention will be indicated in two groups (Melatonin plus metformin and metformin plus placebo) | Drug | melatonin plus metformin, metformin plus placebo |
| PlaceboAlso: Calcined magnesiaThe placebo may be contained in bottles labeled "Medication 1" or "Medication 2" depending on the time of administration, and the group in which it is used. Placebo will be used in two groups (Melatonin plus placebo and Metformin plus placebo) | Drug | melatonin plus placebo, metformin plus placebo |
Primary outcome
Fasting plasma glucose (FPG)
Time frame: Baseline to week 12
The FPG will be evaluate in a blood sample after a 8 - 12 hour fasting period. Will be use a fotometric quantification of glucose levels in plasma sample and will report in mg/dL.
Blood Glucose level after an Oral Glucose tolerance Test
Time frame: Baseline to week 12
Will estimate the glucose levels at 2 hours after administration of 75 grams of anhydrid dextrosa. The result will report in mg/dL.
A1c Hemoglobin Fraction (HbA1C)
Time frame: Baseline to week 12
HbA1c will be measured with High-performance liquid chromatography technique from a blood sample. The result will report in percentage (%).
Micronuclei frequency
Time frame: Baseline to week 12
The frequency of micronuclei will be measured from a cytological sample obtained from the oral epithelium by careful scraping of both cheeks. A fluorescence technique will be performed using acridine orange, as well as a Giemsa-Wrigth stain. The result will be reported in micronucleus frequency per 1000 cells.
Nuclear anomalies frequency
Time frame: Baseline to week 12
The nuclear anomalies frequency will be measured from a cytological sample obtained from the oral epithelium by careful scraping of both cheeks. A fluorescence technique will be performed using acridine orange, as well as a Giemsa-Wrigth stain. They will be divided according to their morphology (multinucleated cells, pyknotic nucleus, karyorrhexis, caryolysis, nuclei buds, condensed chromatin) and will be reported by the number of findings per 1000 cells.
11 secondary outcomes
Body height
Time frame: Baseline to week 12
Body weight
Time frame: Baseline to week 12
Body mass index
Time frame: Baseline to week 12
Insulin Secretion
Time frame: Baseline to week 12
Baseline Insulin Secretion
Time frame: Baseline to week 12
Insulin sensitivity
Time frame: Baseline to week 12
Total Cholesterol
Time frame: Baseline to week 12
High-density lipoprotein (HDL)
Time frame: Baseline to week 12
Low-density lipoprotein
Time frame: Baseline to week 12
Triglycerides
Time frame: Baseline to week 12
Serum Lactate
Time frame: Baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- 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 27302176Brannick B, Wynn A, Dagogo-Jack S. Prediabetes as a toxic environment for the initiation of microvascular and macrovascular complications. Exp Biol Med (Maywood). 2016 Jun;241(12):1323-31. doi: 10.1177/1535370216654227.
- Background: PubMed 21281836Ferrannini E, Gastaldelli A, Iozzo P. Pathophysiology of prediabetes. Med Clin North Am. 2011 Mar;95(2):327-39, vii-viii. doi: 10.1016/j.mcna.2010.11.005.
- Background: PubMed 29080583Wilson ML. Prediabetes: Beyond the Borderline. Nurs Clin North Am. 2017 Dec;52(4):665-677. doi: 10.1016/j.cnur.2017.07.011. Epub 2017 Oct 5.
- Background: PubMed 26059289Hostalek U, Gwilt M, Hildemann S. Therapeutic Use of Metformin in Prediabetes and Diabetes Prevention. Drugs. 2015 Jul;75(10):1071-94. doi: 10.1007/s40265-015-0416-8.
- Background: PubMed 23775102Serrano R, Garcia-Soidan FJ, Diaz-Redondo A, Artola S, Franch J, Diez J, Carrillo L, Ezkurra P, Millaruelo JM, Segui M, Sangros FJ, Martinez-Candela J, Munoz P, Goday A, Regidor E; Grupo de Estudio PREDADS. Cohort Study in Primary Health Care on the Evolution of Patients with Prediabetes (PREDAPS): basis and methodology. Rev Esp Salud Publica. 2013 Mar-Apr;87(2):121-35. doi: 10.4321/S1135-57272013000200003. English, Spanish.
- Background: PubMed 21810068Yang H, Jin X, Kei Lam CW, Yan SK. Oxidative stress and diabetes mellitus. Clin Chem Lab Med. 2011 Nov;49(11):1773-82. doi: 10.1515/CCLM.2011.250. Epub 2011 Aug 3.
- Background: PubMed 21030723Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.
- Background: PubMed 22582044Tang WH, Martin KA, Hwa J. Aldose reductase, oxidative stress, and diabetic mellitus. Front Pharmacol. 2012 May 9;3:87. doi: 10.3389/fphar.2012.00087. eCollection 2012.
- Background: PubMed 16490224Rolo AP, Palmeira CM. Diabetes and mitochondrial function: role of hyperglycemia and oxidative stress. Toxicol Appl Pharmacol. 2006 Apr 15;212(2):167-78. doi: 10.1016/j.taap.2006.01.003. Epub 2006 Feb 20.
- Background: PubMed 11742414Brownlee M. Biochemistry and molecular cell biology of diabetic complications. Nature. 2001 Dec 13;414(6865):813-20. doi: 10.1038/414813a.
- Background: PubMed 24778463Torres-Bugarin O, Zavala-Cerna MG, Nava A, Flores-Garcia A, Ramos-Ibarra ML. Potential uses, limitations, and basic procedures of micronuclei and nuclear abnormalities in buccal cells. Dis Markers. 2014;2014:956835. doi: 10.1155/2014/956835. Epub 2014 Feb 4.
- Individual participant dataSharing planned: Undecided
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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.
Lizet Yadira Rosales-Rivera, PhD Science principal investigator
Instituto de terapeutica experimental y clínica
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 melatonin and metformin in people with PreDiabetes, 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 5 inclusion and 9 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 26 Sep 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lizet Y Rosales-Rivera, PhD Science (52 33 10585200 ext. 34212, lizet.rosales@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (FPG) (time frame: Baseline to week 12). The study lists 5 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 NCT03848533, which also lists 35 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 26 Sep 2019.