The impact of lipoic acid and alpha-tocopherol supplementation in patients with type 2 diabetes mellitus

ISRCTN ISRCTN81379520
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

Av Dr Arnaldo, 715
São PAulo
01246-904
Brazil

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleThe 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 acronymALA and ATO in patients with DM2
Study objectivesIf 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) studiedDiabetes mellitus type II (DM2)
InterventionOne 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 typeOther
Primary outcome measureAssessing 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 measures1. 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 date01/09/2005
Completion date28/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants102
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2005
Date of final enrolment28/02/2006

Locations

Countries of recruitment

  • Brazil

Study participating centre

Av Dr Arnaldo, 715
São PAulo
01246-904
Brazil

Sponsor information

State of São Paulo Research Foundation (FAPESP) (Brazil)
University/education

c/o Liania Alves Luzia
Av Dr Arnaldo, 715
São Paulo
01246-904
Brazil

Email lianialuzia@usp.br
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan