Use of alpha lipoic acid as a complementary treatment for the control of diabetes
| ISRCTN | ISRCTN13159380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13159380 |
| Protocol serial number | IN222015 |
| Sponsor | National Autonomous University of Mexico |
| Funder | National Autonomous University of Mexico |
- Submission date
- 17/04/2017
- Registration date
- 10/05/2017
- Last edited
- 26/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). If not properly controlled, T2DM can lead to a range of complications, such as irreversible damage to the kidneys, eyes and nerves. This is thought to occur because high blood sugar levels leads to an increase of free radicals, which cause irreversible damage to the body’s cells (oxidative stress). Antioxidants are substances which are able to essentially “neutralize” free radicals in the body, and can be found in a range of vitamins and minerals. Alpha lipoic acid (ALA) is a naturally occurring antioxidant made in the body, which helps to support cellular processes. Recent studies have suggested that taking ALA supplements could be an effective way of treating long-term conditions such as diabetes by reducing oxidative stress. The aim of this study is to evaluate the effects of ALA supplements on oxidative stress and blood sugar control in diabetic older adults.
Who can participate?
Adults aged 60-74 who have been diagnosed with T2DM.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are asked to take two capsules that contain ALA every day for 12 months. Those in the second group are asked to take two capsules that contain a placebo (dummy drug) every day for 12 months. At the start of the study and then after six and 12 months, participants in both groups have their blood pressure measured using an automated blood pressure cuff and have blood samples taken to assess levels of oxidative stress and how well they are controlling their blood sugar levels.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
1. University health care clinic “Zaragoza” (Mexico)
2. Gerontology Research Unit of “Facultad de Estudios Superiores Zaragoza, UNAM” (Mexico)
3. Institute of Social Security and Services of State Workers (ISSSTE) “Ignacio Zaragoza” (Mexico)
When is the study starting and how long is it expected to run for?
September 2014 to October 2017
Who is funding the study?
National Autonomous University of Mexico (Mexico)
Who is the main contact?
Dr Víctor Manuel Mendoza-Nuñez
Contact information
Scientific
Avenida Universidad # 3000
Ciudad Universitaria
Delegación Coyoacán
CDMX
Mexico City
04510
Mexico
 ORCID ID |
0000-0002-9137-3405 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of alpha lipoic acid on glycemic control, oxidative stress and inflammation markers in older adults with type 2 diabetes mellitus |
| Study objectives | According to scientific evidence about hypoglycemic effect of alpha lipoic acid, diabetic patients who will receive this compound will show improvement on glycemic control and will avoid complications due to T2DM. |
| Ethics approval(s) | Bioethics and Biosafety Committee of the Research Committee of “Facultad de Estudios Superiores Zaragoza, UNAM”, 12/01/2015, ref: 25/11/SO/3.4.3 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Following provision of informed consent, participants are randomised to one of two groups. At baseline, blood samples will be taken to assess levels of oxidative stress, inflammation and glycemic control. Intervention group: Participants take two capsules containing 300 mg of ALA daily for 12 months Control group: Participants take two capsules containing a placebo daily for 12 months After 6 and 12 months, the initial blood tests are repeated to evaluate whether there has been an improvement in those in the group that received ALA. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ALA |
| Primary outcome measure(s) |
1. Oxidative stress is assessed by measuring the levels of SOD, GPx, TAS, TBARS and isoprostane markers measured in blood and plasma by spectrophotometry and ELISA, respectively, at baseline, 6 and 12 months |
| Key secondary outcome measure(s) |
1. Serum glucose levels and the lipid profile determined by spectrophometry, both performed in serum at the beginning of the study, 6 and 12 months |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 135 |
| Key inclusion criteria | 1. Aged 60 to 74 years old 2. Diagnosed with T2DM 3. No renal damage 4. Provision of informed consent |
| Key exclusion criteria | 1. People who have taken antioxidant supplements or anti-inflammatory drugs in the last 6 month 2. With hypothyroidism 3. Who presenting problems of digestive tract absorption or have been submitted to gastric surgery 4. With liver failure 5. Hypersensitivity to ALA |
| Date of first enrolment | 01/08/2016 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Mexico City
09230
Mexico
Mexico City
09230
Mexico
Mexico City
09208
Mexico
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/06/2019 | 26/11/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
