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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81379520

Enrollment

102

Registered

2010-08-12

Start date

2005-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type II (DM2) Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 pa

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026