Melatonin administration lowers biomarkers of oxidative stress and cardio-metabolic risk in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial.
Study Goal
The researchers aimed to evaluate the effects of melatonin administration on metabolic status in diabetic patients with coronary heart disease (CHD).
Results Summary
Melatonin supplementation significantly improved oxidative stress markers (GSH, NO, MDA, PCO), reduced inflammation (hs-CRP), enhanced glycemic control, improved lipid profiles, and lowered blood pressure compared to placebo.
Population
Diabetic patients with coronary heart disease (n=60).
Effective Dosage
10 mg melatonin (2 capsules of 5 mg each) once daily.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin administration | increase | plasma glutathione (GSH) | diabetic patients with CHD | +64.7 ± 105.7 vs. -11.1 ± 137.6 μmol/L | resulted in significant increases | #1 |
melatonin administration | increase | nitric oxide (NO) | diabetic patients with CHD | +0.9 ± 4.7 vs. -3.3 ± 9.6 μmol/L | resulted in significant increases | #2 |
melatonin administration | decrease | malondialdehyde (MDA) | diabetic patients with CHD | -0.2 ± 0.3 vs. +0.1 ± 0.5 μmol/L | resulted in significant decreases | #3 |
melatonin administration | decrease | protein carbonyl (PCO) | diabetic patients with CHD | -0.12 ± 0.08 vs. +0.03 ± 0.07 mmol/mg protein | resulted in significant decreases | #4 |
melatonin administration | decrease | serum high sensitivity C-reactive protein (hs-CRP) levels | diabetic patients with CHD | -1463.3 ± 2153.8 vs. +122.9 ± 1230.4 ng/mL | resulted in significant decreases | #5 |
melatonin supplementation | decrease | fasting plasma glucose | diabetic patients with CHD | -29.4 ± 49.0 vs. -5.5 ± 32.4 mg/dL | significantly reduced | #6 |
melatonin supplementation | decrease | serum insulin concentrations | diabetic patients with CHD | -2.2 ± 4.1 vs. +0.7 ± 4.2 μIU/mL | significantly reduced | #7 |
melatonin supplementation | decrease | homeostasis model of assessment-estimated insulin resistance | diabetic patients with CHD | -1.0 ± 2.2 vs. +0.01 ± 1.6 | significantly reduced | #8 |
melatonin supplementation | decrease | total-/HDL-cholesterol ratio | diabetic patients with CHD | -0.18 ± 0.38 vs. +0.03 ± 0.35 | significantly reduced | #9 |
melatonin supplementation | decrease | systolic blood pressure | diabetic patients with CHD | -4.3 ± 9.6 vs. +1.0 ± 7.5 mmHg | significantly reduced | #10 |
melatonin supplementation | decrease | diastolic blood pressure | diabetic patients with CHD | -2.8 ± 7.3 vs. +0.1 ± 3.6 mmHg | significantly reduced | #11 |
melatonin treatment | increase | quantitative insulin sensitivity check index | diabetic patients with CHD | +0.006 ± 0.01 vs. -0.004 ± 0.01 | significantly increased | #12 |
melatonin treatment | increase | serum HDL-cholesterol | diabetic patients with CHD | +2.6 ± 5.5 vs. -0.01 ± 4.4 mg/dL | significantly increased | #13 |
Supplementation with melatonin | no change | other metabolic parameters | diabetic patients with CHD | no significant change | had no significant effect | #14 |
BACKGROUND & AIMS: Melatonin may benefit diabetic people with coronary heart disease (CHD) through its beneficial effects on biomarkers of oxidative stress and cardio-metabolic risk. This investigation evaluated the effects of melatonin administration on metabolic status in diabetic patients with CHD. METHODS: This randomized, double-blind, placebo-controlled trial was conducted and involved 60 diabetic patients with CHD. Subjects were randomly allocated into two groups to receive either 10 mg melatonin (2 melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day for 12 weeks. RESULTS: Compared with the placebo, melatonin supplementation resulted in significant increases in plasma glutathione (GSH) (+64.7 ± 105.7 vs. -11.1 ± 137.6 μmol/L, P = 0.02) and nitric oxide (NO) (+0.9 ± 4.7 vs. -3.3 ± 9.6 μmol/L, P = 0.03), and significant decreases in malondialdehyde (MDA) (-0.2 ± 0.3 vs. +0.1 ± 0.5 μmol/L, P = 0.007), protein carbonyl (PCO) (-0.12 ± 0.08 vs. +0.03 ± 0.07 mmol/mg protein, P < 0.001) and serum high sensitivity C-reactive protein (hs-CRP) levels (-1463.3 ± 2153.8 vs. +122.9 ± 1230.4 ng/mL, P = 0.001). In addition, taking melatonin, compared with the placebo, significantly reduced fasting plasma glucose (-29.4 ± 49.0 vs. -5.5 ± 32.4 mg/dL, P = 0.03), serum insulin concentrations (-2.2 ± 4.1 vs. +0.7 ± 4.2 μIU/mL, P = 0.008), homeostasis model of assessment-estimated insulin resistance (-1.0 ± 2.2 vs. +0.01 ± 1.6, P = 0.04), total-/HDL-cholesterol ratio (-0.18 ± 0.38 vs. +0.03 ± 0.35, P = 0.02) and systolic (-4.3 ± 9.6 vs. +1.0 ± 7.5 mmHg, P = 0.01) and diastolic blood pressure (-2.8 ± 7.3 vs. +0.1 ± 3.6 mmHg, P = 0.04). Melatonin treatment also significantly increased quantitative insulin sensitivity check index (+0.006 ± 0.01 vs. -0.004 ± 0.01, P = 0.01) and serum HDL-cholesterol (+2.6 ± 5.5 vs. -0.01 ± 4.4 mg/dL, P = 0.04). Supplementation with melatonin had no significant effect on other metabolic parameters. CONCLUSIONS: Overall, melatonin intake for 12 weeks to diabetic patients with CHD had beneficial effects on plasma GSH, NO, MDA, PCO, serum hs-CRP levels, glycemic control, HDL-cholesterol, total-/HDL-cholesterol ratio, blood pressures and parameters of mental health. Registered under ClinicalTrials.gov Identifier no. http://www.irct.ir: IRCT2017051333941N1.