Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/04/2017
Date assigned
10/05/2017
Last edited
08/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Víctor Manuel Mendoza Nuñez

ORCID ID

http://orcid.org/0000-0002-9137-3405

Contact details

Avenida Universidad # 3000
Ciudad Universitaria
Delegación Coyoacán
CDMX
Mexico City
04510
Mexico

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IN222015

Study information

Scientific title

Effect of alpha lipoic acid on glycemic control, oxidative stress and inflammation markers in older adults with type 2 diabetes mellitus

Acronym

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

ALA

Primary outcome measures

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 trial start date

06/09/2014

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 to 74 years old
2. Diagnosed with T2DM
3. No renal damage
4. Provision of informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

Trial participating centre

University health care clinic “Zaragoza”
Guelatao # 66 Colonia Ejército de Oriente Delegación Iztapalapa
Mexico City
09230
Mexico

Trial participating centre

Gerontology Research Unit of “Facultad de Estudios Superiores Zaragoza, UNAM”
Batalla 5 de Mayo SN, Ejèrcito de Oriente, Delegación Iztapalapa
Mexico City
09230
Mexico

Trial participating centre

Institute of Social Security and Services of State Workers (ISSSTE) “Ignacio Zaragoza”
Calzada Ignacio Zaragoza #1711, Chinampac de Juárez, Delegación Iztapalapa
Mexico City
09208
Mexico

Sponsor information

Organisation

National Autonomous University of Mexico

Sponsor details

J.C. Bonilla 66
Ejercito de Oriente
Delegación Iztapalapa
Mexico City
09230
Mexico
+52 562 307 21
mendovic@servidor.unam.mx

Sponsor type

University/education

Website

http://www.zaragoza.unam.mx/

Funders

Funder type

University/education

Funder name

National Autonomous University of Mexico

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes