Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
ALA and ATO in patients with DM2
Study hypothesis
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
The local ethics committee approved on the 19th of August 2004 (ref:128/04)
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
Primary outcome measures
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 trial start date
01/09/2005
Overall trial end date
28/02/2006
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
102
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
28/02/2006
Locations
Countries of recruitment
Brazil
Trial participating centre
Av Dr Arnaldo, 715
São PAulo
01246-904
Brazil
Sponsor information
Organisation
State of São Paulo Research Foundation (FAPESP) (Brazil)
Sponsor details
c/o Liania Alves Luzia
Av Dr Arnaldo
715
São Paulo
01246-904
Brazil
lianialuzia@usp.br
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
State of São Paulo Research Foundation (FAPESP) (Brazil) (ref: 04/04108-1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary