Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/06/2010
Date assigned
12/08/2010
Last edited
12/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Liania Luzia

ORCID ID

Contact details

Av Dr Arnaldo
715
São PAulo
01246-904
Brazil

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

Publication citations

Additional files

Editorial Notes