Use of alpha lipoic acid as a complementary treatment for the control of diabetes

Category Primary study
Registry of TrialsISRCTN registry
Year 2017
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. CONDITION: Type 2 diabetes mellitus ; Nutritional, Metabolic, Endocrine ; Type 2 diabetes mellitus PRIMARY OUTCOME: 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‐a, IL‐1ß, 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: 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; INCLUSION CRITERIA: 1. Aged 60 to 74 years old 2. Diagnosed with T2DM 3. No renal damage 4. Provision of informed consent
Epistemonikos ID: 8c5303feab9059572031900116c9e9843bd55cf3
First added on: Aug 23, 2024