The impact of lipoic acid and alpha-tocopherol supplementation in patients with type 2 diabetes mellitus
ISRCTN | ISRCTN81379520 |
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DOI | https://doi.org/10.1186/ISRCTN81379520 |
Secondary identifying numbers | N/A |
- Submission date
- 16/06/2010
- Registration date
- 12/08/2010
- Last edited
- 12/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Liania Luzia
Scientific
Scientific
Av Dr Arnaldo, 715
São PAulo
01246-904
Brazil
Study information
Study design | Randomised double blind placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
Scientific title | The impact of alpha-lipoic acid and alpha-tocopherol supplementation in the control of insulin resistance and other metabolic syndrome components in patients with type 2 diabetes mellitus: A double-blind, randomised, placebo-controlled trial |
Study acronym | ALA and ATO in patients with DM2 |
Study objectives | If the introduction of combined antioxidant alpha-lipoic acid (ALA) and alpha-tocopherol (ATO) modifies the components of the Metabolic Syndrome in patients with type-2 Diabetes mellitus. |
Ethics approval(s) | The local ethics committee approved on the 19th of August 2004 (ref:128/04) |
Health condition(s) or problem(s) studied | Diabetes mellitus type II (DM2) |
Intervention | One or two types of antioxidants or placebo for a period of four months (16 weeks) 1. 28 patients received a supplement consisting of 600 mg / day of lipoic acid and 800 mg / day of vitamin E 2. 28 patients received a supplement consisting of 600 mg / day of lipoic acid 3. 28 patients received a supplement consisting of 800 mg / day of vitamin E 4. 28 patients received placebo |
Intervention type | Other |
Primary outcome measure | Assessing the impact of supplemental antioxidants vitamin E and lipoic acid in the indicators of metabolic syndrome in patients with DM2. All outcomes were measured at baseline and post-treatment (i.e. 16 weeks) |
Secondary outcome measures | 1. Assessing the impact of combined supplementation of antioxidants alone and in insulin resistance, as detected by the method HOMA (Homeostasis Model Assessment) in patients with DM2 2. Determine the serum levels of vitamin E in patients with DM2 before and after supplementation with antioxidants 3. To evaluate the effect of supplementation with antioxidants in the biochemical indicators of MS patients with DM2 before and after the intervention 4. To evaluate anthropometric measurements before and after supplementation with antioxidants All outcomes were measured at baseline and post-treatment (i.e. 16 weeks) |
Overall study start date | 01/09/2005 |
Completion date | 28/02/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 102 |
Key inclusion criteria | 1. Aged 38-75 years 2. Patients with type II diabetes mellitus (DM2) 3. Registered in the Integrated Health Center (NIS) and Polyclinics in Jundiai, Brazil 4. At least two years of disease diagnosis 5. Without the presence of episodes of cetocidose and A1c less than 9.0% (data from the last examination until four months before the screening) |
Key exclusion criteria | 1. Insulin therapy at baseline or in the segment of the research 2. Taking vitamin supplements with lipoic acid and/or vitamin E in the formulation 3. Pregnant status or become pregnant during the study 4. Smokers consuming more than 10 cigarettes/day 5. Daily intake alcoholic beverages 6. Presence of renal and/or cardiovascular disease 7. DM2 decompensation due to infection 8. Change or introduction of new medication 9. Family history of autoimmune disease |
Date of first enrolment | 01/09/2005 |
Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av Dr Arnaldo, 715
São PAulo
01246-904
Brazil
01246-904
Brazil
Sponsor information
State of São Paulo Research Foundation (FAPESP) (Brazil)
University/education
University/education
c/o Liania Alves Luzia
Av Dr Arnaldo, 715
São Paulo
01246-904
Brazil
lianialuzia@usp.br | |
https://ror.org/02ddkpn78 |
Funders
Funder type
Research organisation
State of São Paulo Research Foundation (FAPESP) (Brazil) (ref: 04/04108-1)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |