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Table 2 Clinical studies with ALA in patients with diabetes

From: Alpha-lipoic acid as a pleiotropic compound with potential therapeutic use in diabetes and other chronic diseases

Author Study type ALA/other drugs Analyzed parameters Total participants Duration of DM (years) Follow up (weeks/ years) Results
Type 2 diabetes treatment
Udupa, AS [134] Randomized, double- blind placebo-controlled Vitamin E, omega 3 fatty acids ALA 300 mg All of them daily/orally Weight, waist glucose 104 with IR 5-10 y 12 w < HbA1c, weight, waist Better results with omega-3 followed by vitamin E and ALA
Porasuphatana S [135] Randomized, placebo- controlled ALA 300 mg -1200 mg/d HbA1c, FBG 38 2.07 ± 0.26 24 w <HbA1c, FBG
De Oliveira AM [136] Randomized, double- blind placebo-controlled ALA 600 mg or Vitamin E 800 mg or ALA 600 mg plus Vitamin E 800 mgr HOMA index, glucose, lipid profile insulin 102   16 w  
Diabetic retinopathy
Haritoglou C [139] Randomized ,double-blind placebo-controlled ALA 600 mg/daily Development of macular edema 232 patients with type 2 and 170 with T1D   86 w no effect
Nebioso M [140] Randomized not placebo-controlled ALA 400 mg daily plus vitamins and genistein ERG 32 NA 4 w Improvement in ERG
Diabetic nephropathy
Borcea V [143] Cross-sectional not placebo-controlled ALA 600 mg/daily/orally Lipid ROOH, HbA1c, urine albumin, α tocopherol 107 patients [45 with T1D and 29 with T2D] 21.7 ± 11.1 (with ALA); 15.3 ± 10.4 (without ALA) >12 w < ROOH < ROOH/(,α tocopherol/cholesterol The decrease was independent of HbA1c and urine albumin level
Cicek M [144] Randomized not placebo-controlled ALA 600 mg/ /orally CIN Plasma creatinine, Cystation C 79 NA Prior coronary angiography No effect in the incidence of CIN, creatinine, Cystatin C pré /pos exam
Chang JW [145] Randomized placebo-controlled ALA 600 mg/orally Cholesterol, HbA1c C-reactive protein, oxidizedLDL- ADMA 50 patients on hemodyalisis treatment NA 12 w Decrease the level of ADMA
Diabetes endothelial dysfunction
Heinisch BB [147] Randomized, Controlled,double- blind placebo parallel Daily 600 mg of ALA IV Endothelial function endothelium dependent and independent HbA1c, lipid profile 30 patients with TD2 7 ± 6 3 w Improvement in endothelium dependent function
Diabetic cardiovascular autonomic neuropathy
Pop-Busui R [150] Prospective, randomized, double- blind, placebo- controlled ALA 600 mg/twice daily Nicotinamide 750 mg/twice daily Allupurinol 300 mg/daily All of them orally Autonomic tests PET F2 urinary isoprostane HbA1c 44 patients with T1D with mild/moderate cardiovascular autonomic neuropathy and retinopathy or microalbuminuria 27 ± 12 2 y No improvement in any analyzed parameter
Ziegler D [151] Randomized, double- blind, placebo- controlled ALA 800 mg/daily (orally) Heart rate variability HbA1c Autonomic symptoms 73 patients with T2D 15.3 ± 8.3 16 w Improvement on root mean square successive difference and power spectrum in low frequency band No difference in the prevalence of symptoms
Diabetic polyneuropathy
ZiegleR D [153] ALADIN I Randomized,double- blind controlled parallel ALA:1200 or 600 or 100 mg/daily (orally) TSS HbA1c 328 patients with T2D with symptomatic peripheral neuropathy 10.4/12.3 3 w Improvement in TSS HbA1c: no difference
Reljanovic M [154] ALADIN II Prospective randomized,double- blind controlled ALA 1200 mg or 600 mg orally Sensory and motor nerve function 299 patients (T1D and T2D) with symptomatic polyneuropathy NA 2 y Improvement in electrophysiological tests HbA1c: no difference
Ziegler D.[155] ALADIN III Prospective randomized, double- blind controlled ALA 600 mg/ IV followed by 1800 mg of ALA or placebo orally TSS NIS 516 patients with T2D with symptomatic polyneuropathy 11 3 w (IV) 24 w (orally) No effect HbA1c:no difference
Ametov As [157] Sidney I Randomized, double- blind ,parallel controlled, mono-center ALA 600 mg IV TSS 120 (T1D and T2D) with DSPN 15.1 ± 8.8 3 Improvement
Ziegler D [158] Sidney II Randomized, double- blind, parallel controlled, multicenter ALA 600 to 1800 mg/orally TSS 181 (T1D and T2D) with DSPN 14 5 Improvement
Ziegler D [159] Nathan I Randomized, double- blind, parallel controlled, multicenter ALA 600 mg/orally TSS Composite score( NIS–lower limbs plus 7 neurophisiologic tests (NIS-LL+7) 460 (T1D and T2D) with DSPN 13.3 4 years TSS: no improvement NSI-LL+7:improvement
Ziegler D [160] Meta-analysis ALA 600mg IV TSS, NIS-LL 1258 132 months 3 w Improvement in TSS (papin-prick,touch-pressure), burning,numbness) Improvement in NIS-LL
Mijnhout GS [161] Meta-analysis ALA orally ( 600 to 1800 mg daily) ALA IV (100 to 1200 mg/daily) TSS 653 NA 3 to 5 w Improvement in TSS but greater than 30% only in intravenously treated patients
  1. ALA, alpha-lipoic acid; w, weeks; y, years; IV, intravenously; HbA1c, glycated hemoglobin; FBG, fasting blood glucose; HOMA index, homeostasis model assessment; ERG, electroretinogram; ROOH, hidroxiperoxides; CIN, contrast induced nephropathy; ADMA, asymmetric dimethyl-arginine; PET, positron emission tomography; TSS, total symptoms score; NIS, neurophaty impairment score; NIS-LL, neuropathy improvement score of lower limbs; T1D, type 1 diabetes; T2D, type 2 diabetes; IR, insulin resistance; DSPN , distal symmetric sensory-motor polyneuropathy.