Diabetes MellitusNCT01477112
Low Dose β-carotene Supplementation Diminishes Oxidative Stress in Type 2 Diabetics and Healthy Individuals
A study testing Betacarotene in people with Diabetes Mellitus and Oxidative Stress, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.
Trial summary
Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Oxidative Stress, Iron Metabolism Disorders
- What is being tested?
- Betacarotene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteVenezuela
- Study dates
- Jan 2010to Dec 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a diagnose of Type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics Patients in regular control (once a month) in the Hospital
Who cannot join
- Hospitalized patient
- Diabetic patient with diabetes related acute complications (ketoacidosis, hyperosmolar coma)in the 3 months previous to the study.
- Individuals with infections that required antibiotics in the 3 weeks previous to the study.
- Individuals with antibodies anti-insulin, autoimmune diseases or in treatment with immunosuppressive drugs.
- Individuals with viral infections such as hepatitis B, hematological, renal or hepatic diseases.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Supplementation With β-carotene to Type 2 Diabetic Patients and Healthy Controls on the Iron Status and Antioxidant Capacity of Plasma
Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
Read the detailed description
Type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. The objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
A total of 117 volunteers participated in the study. Type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. Blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, HDL, LDL, oxidized LDL, copper, zinc, TBARS, FRAP, nitrites, GPx, SOD, folates, retinol and β-carotene.
- Being tested
- Betacarotene, Controls. No treatment
- Keywords
- Type 2 diabetes, β-carotene, Oxidative balance, Oxidants, Antioxidants
- Medical subject headings
- Diabetes Mellitus, Iron Metabolism Disorders, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetacaroteneDietary supplement
Also called β-carotene as a soft gel capsule (GNC, Pennsylvania-USA)
6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation
Controls. No treatmentDietary supplement
Also called No supplements
Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements
| Study group | Role | What they receive |
|---|---|---|
| Supplemented Diabetics (DB) | Experimental | Diabetics supplemented with betacarotene for 45 days Receives: Dietary Supplement: Betacarotene |
| Unsupplemented Diabetics (DS) | Experimental | Diabetics without betacarotene supplementation Receives: Dietary Supplement: Controls. No treatment |
| Supplemented Controls (CB) | Active comparator | Controls supplemented with betacarotene for 45 days Receives: Dietary Supplement: Betacarotene |
| Unsupplemented Controls (CS) | Active comparator | Controls without betacarotene supplementation Receives: Dietary Supplement: Controls. No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in oxidative status
Measured: Time 0, 45 days and 75 days after supplementation
Secondary outcomes (14)
Hemoglobin and hematocrit
Measured: Time 0, 45 days and 75 days after supplementation
Ferritin
Enzyme linked immunosorbent assay (ELISA) with monoclonal antibodies
Measured: Time 0, 45 days and 75 days after supplementation
Iron metabolism markers
Serum iron, total iron binding capacity (TIBC) and unsaturated iron binding capacity (UIBC) were determined by the methods proposed by the International Committee of Standardization of Hematology.
Measured: Time 0, 45 days and 75 days after supplementation
Blood Chemistry
Glycemia, triglycerides, total cholesterol, LDL, and HDL were determined automatically in a Ciba Corning 550 Express autoanalizer, using classic enzymatic methods for the determination of these variables.
Measured: Time 0, 45 days and 75 days after supplementation
Glycosylated Hemoglobin
It was determined using a commercial kit (Bioscience, Caracas, Venezuela),
Measured: Time 0, 45 days and 75 days after supplementation
Oxidized LDL
Analyzed by a solid phase two-site enzyme immunoassay from Mercodia (Sweden), which contains 2 monoclonal antibodies directed against separated antigenic determinants on the oxidized apolipoprotein B molecule.
Measured: Time 0, 45 days and 75 days after supplementation
Thiobarbituric Acid Reactive substances (TBARS)
Were detected by the quantification of malondialdehyde present in the sample, by reacting 2 molecules of thiobarbituric acid with 1 molecule of malondialdehyde, which produces an abduct that is detected at 535 mn.
Measured: Time 0, 45 days and 75 days after supplementation
Ferric Reducing ability of Plasma (FRAP).
Measured after 4 and 10 min incubation, was used to determine the ability of plasma to reduce iron from ferric to ferrous state, based on the formation of a triazine-Fe+3 complex, that when reduced to Fe+2, generate a change in color that is measured at 593 nm.
Measured: Time 0, 45 days and 75 days after supplementation
Activities of the enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx).
Determined by commercial kits (Cayman Chemicals, Pittsburg) following the recommended protocols
Measured: Time 0, 45 days and 75 days after supplementation
Serum zinc and copper.
By flame atomic absorption spectrophotometry
Measured: Time 0, 45 days and 75 days after supplementation
β-carotene.
It was determined by HPLC, with a reverse fase C18 column.
Measured: Time 0, 45 days and 75 days after supplementation
Serum retinol
It was determined by HPLC, with a reverse fase C18 column, as an indirect measure of betacarotene metabolism.
Measured: Time 0, 45 days and 75 days after supplementation
Serum nitrites
Were determined as an indirect measure of the concentration of nitric oxide, since nitrites are the stable end products of its degradation. Nitrates were reduced to nitrites by activated cadmium. Then sulfanilamide and nitrites generate a chromophore that reacts with naftilethylenediamine, to generate a product visible at 540 nm.
Measured: Time 0, 45 days and 75 days after supplementation
Serum and erythrocyte folates.
The method is based in the folate-dependent controlled growth of a Lactobacillus strain that is measured spectrophotometrically and quantified against a standard curve.
Measured: Time 0, 45 days and 75 days after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Venezolano de Investigaciones Cientificas
- Sponsor type
- University, hospital or other
- Collaborators
- Seguros Caracas Foundation, National Fund for Science and Technology, Science Mission
- Responsible party
- Principal investigator, Maria Nieves Garcia-Casal, Instituto Venezolano de Investigaciones Cientificas
- Investigators
- Maria N Garcia-Casal, PhD, Study director, Instituto Venezolano de Investigaciones CientificasJose M Moreno, PhD, Principal investigator, Instituto Venezolanode Investigaciones cientificas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477112
- Sponsor's protocol ID
- IVIC-HUMNUT-001
- Status last verified
- Nov 2011
- First submitted
- 15 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ford ES, Cogswell ME. Diabetes and serum ferritin concentration among U.S. adults. Diabetes Care. 1999 Dec;22(12):1978-83. doi: 10.2337/diacare.22.12.1978.
PubMed 10587829Ford ES, Mokdad AH, Giles WH, Brown DW. The metabolic syndrome and antioxidant concentrations: findings from the Third National Health and Nutrition Examination Survey. Diabetes. 2003 Sep;52(9):2346-52. doi: 10.2337/diabetes.52.9.2346.
PubMed 12941775Sugiura M, Nakamura M, Ikoma Y, Yano M, Ogawa K, Matsumoto H, Kato M, Ohshima M, Nagao A. The homeostasis model assessment-insulin resistance index is inversely associated with serum carotenoids in non-diabetic subjects. J Epidemiol. 2006 Mar;16(2):71-8. doi: 10.2188/jea.16.71.
PubMed 16537987Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effects of vitamins C and E and beta-carotene on the risk of type 2 diabetes in women at high risk of cardiovascular disease: a randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):429-37. doi: 10.3945/ajcn.2009.27491. Epub 2009 Jun 2.
PubMed 19491386
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Supplementation With β-carotene to Type 2 Diabetic Patients and Healthy Controls on the Iron Status and Antioxidant Capacity of Plasma
- ClinicalTrials.gov ID
- NCT01477112
- Acronym / sponsor ID
- IVIC-HUMNUT-001
- Keywords
- Type 2 diabetes, β-carotene, Oxidative balance, Oxidants, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Instituto Venezolano de Investigaciones CientificasUniversity, hospital or other
- Collaborators
- Seguros Caracas Foundation, National Fund for Science and Technology, Science Mission
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
Detailed description
Type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. The objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
A total of 117 volunteers participated in the study. Type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. Blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, HDL, LDL, oxidized LDL, copper, zinc, TBARS, FRAP, nitrites, GPx, SOD, folates, retinol and β-carotene.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplemented Diabetics (DB) | Experimental | Dietary Supplement: BetacaroteneDiabetics supplemented with betacarotene for 45 days |
| Unsupplemented Diabetics (DS) | Experimental | Dietary Supplement: Controls. No treatmentDiabetics without betacarotene supplementation |
| Supplemented Controls (CB) | Active comparator | Dietary Supplement: BetacaroteneControls supplemented with betacarotene for 45 days |
| Unsupplemented Controls (CS) | Active comparator | Dietary Supplement: Controls. No treatmentControls without betacarotene supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnose of Type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics Patients in regular control (once a month) in the Hospital
Key exclusion criteria (6 listed)
- Hospitalized patient
- Diabetic patient with diabetes related acute complications (ketoacidosis, hyperosmolar coma)in the 3 months previous to the study.
- Individuals with infections that required antibiotics in the 3 weeks previous to the study.
- Individuals with antibodies anti-insulin, autoimmune diseases or in treatment with immunosuppressive drugs.
- Individuals with viral infections such as hepatitis B, hematological, renal or hepatic diseases.
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 |
|---|---|---|
| BetacaroteneAlso: β-carotene as a soft gel capsule (GNC, Pennsylvania-USA)6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation | Dietary supplement | Supplemented Controls (CB), Supplemented Diabetics (DB) |
| Controls. No treatmentAlso: No supplementsEvaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements | Dietary supplement | Unsupplemented Controls (CS), Unsupplemented Diabetics (DS) |
Primary outcome
Changes in oxidative status
Time frame: Time 0, 45 days and 75 days after supplementation
14 secondary outcomes
Hemoglobin and hematocrit
Time frame: Time 0, 45 days and 75 days after supplementation
Ferritin
Time frame: Time 0, 45 days and 75 days after supplementation
Iron metabolism markers
Time frame: Time 0, 45 days and 75 days after supplementation
Blood Chemistry
Time frame: Time 0, 45 days and 75 days after supplementation
Glycosylated Hemoglobin
Time frame: Time 0, 45 days and 75 days after supplementation
Oxidized LDL
Time frame: Time 0, 45 days and 75 days after supplementation
Thiobarbituric Acid Reactive substances (TBARS)
Time frame: Time 0, 45 days and 75 days after supplementation
Ferric Reducing ability of Plasma (FRAP).
Time frame: Time 0, 45 days and 75 days after supplementation
Activities of the enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx).
Time frame: Time 0, 45 days and 75 days after supplementation
Serum zinc and copper.
Time frame: Time 0, 45 days and 75 days after supplementation
β-carotene.
Time frame: Time 0, 45 days and 75 days after supplementation
Serum retinol
Time frame: Time 0, 45 days and 75 days after supplementation
Serum nitrites
Time frame: Time 0, 45 days and 75 days after supplementation
Serum and erythrocyte folates.
Time frame: Time 0, 45 days and 75 days after supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Background: PubMed 10587829Ford ES, Cogswell ME. Diabetes and serum ferritin concentration among U.S. adults. Diabetes Care. 1999 Dec;22(12):1978-83. doi: 10.2337/diacare.22.12.1978.
- Background: PubMed 12941775Ford ES, Mokdad AH, Giles WH, Brown DW. The metabolic syndrome and antioxidant concentrations: findings from the Third National Health and Nutrition Examination Survey. Diabetes. 2003 Sep;52(9):2346-52. doi: 10.2337/diabetes.52.9.2346.
- Background: PubMed 16537987Sugiura M, Nakamura M, Ikoma Y, Yano M, Ogawa K, Matsumoto H, Kato M, Ohshima M, Nagao A. The homeostasis model assessment-insulin resistance index is inversely associated with serum carotenoids in non-diabetic subjects. J Epidemiol. 2006 Mar;16(2):71-8. doi: 10.2188/jea.16.71.
- Background: PubMed 19491386Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effects of vitamins C and E and beta-carotene on the risk of type 2 diabetes in women at high risk of cardiovascular disease: a randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):429-37. doi: 10.3945/ajcn.2009.27491. Epub 2009 Jun 2.
- American Diabetes AssociationLink 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.
Maria N Garcia-Casal, PhD study director
Instituto Venezolano de Investigaciones Cientificas
Jose M Moreno, PhD principal investigator
Instituto Venezolanode Investigaciones cientificas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betacarotene in people with Diabetes Mellitus and Oxidative Stress, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.
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 1 inclusion and 6 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 22 Nov 2011. 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 Venezuela. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in oxidative status (time frame: Time 0, 45 days and 75 days after supplementation). 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 NCT01477112, which also lists 4 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 22 Nov 2011.