se of alpha lipoic acid as a complementary treatment for the control of diabetes
Not Applicable
Completed
- Conditions
- Type 2 diabetes mellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN13159380
- Lead Sponsor
- ational Autonomous University of Mexico
- Brief Summary
2019 results in https://pubmed.ncbi.nlm.nih.gov/31285784/ (added 26/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
1. Aged 60 to 74 years old
2. Diagnosed with T2DM
3. No renal damage
4. Provision of informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 2. Inflammation is assessed by measuring serum levels of TNF-a, IL-1ß, IL-6, IL-8, IL-1, IL-12p70 by flow cytometry and PCR by turbidimetry at baseline, 6 and 12 months<br> 3. Glycemic control is assessed by measuring HbA1c by turbidimetry and RAGE by ELISA, at baseline, 6 and 12 months<br>
- Secondary Outcome Measures
Name Time Method <br> 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<br> 2. Blood pressure was measured using mercury sphygmomanometer, at baseline, 6 and 12 months<br>