Use of alpha lipoic acid as a complementary treatment for the control of diabetes
| ISRCTN | ISRCTN13159380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13159380 |
| Secondary identifying numbers | IN222015 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ALA |
| Primary outcome measure | 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 2. Inflammation is assessed by measuring serum levels of TNF-α, IL-1β, IL-6, IL-8, IL-1, IL-12p70 by flow cytometry and PCR by turbidimetry at baseline, 6 and 12 months 3. Glycemic control is assessed by measuring HbA1c by turbidimetry and RAGE by ELISA, at baseline, 6 and 12 months |
| Secondary outcome measures | 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 2. Blood pressure was measured using mercury sphygmomanometer, at baseline, 6 and 12 months |
| Overall study start date | 06/09/2014 |
| Overall study end date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 135 |
| Participant inclusion criteria | 1. Aged 60 to 74 years old 2. Diagnosed with T2DM 3. No renal damage 4. Provision of informed consent |
| Participant 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 |
| Recruitment start date | 01/08/2016 |
| Recruitment end date | 30/09/2016 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Mexico City
09230
Mexico
Mexico City
09230
Mexico
Mexico City
09208
Mexico
Sponsor information
University/education
J.C. Bonilla 66
Ejercito de Oriente
Delegación Iztapalapa
Mexico City
09230
Mexico
| Phone | +52 562 307 21 |
|---|---|
| mendovic@servidor.unam.mx | |
| Website | http://www.zaragoza.unam.mx/ |
"ROR" |
https://ror.org/01tmp8f25 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal in 2018. |
| 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 |
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.
