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
Protocol serial number	N/A
Sponsor	State of São Paulo Research Foundation (FAPESP) (Brazil)
Funder	State of São Paulo Research Foundation (FAPESP) (Brazil) (ref: 04/04108-1)

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

Primary study design	Interventional
Study design	Randomised double blind placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	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)
Completion date	28/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes