Melatonin Supplementation Improves Cognitive Function in Type-2 Diabetes Mellitus: A Quasi-Experimental Study
Abstract
Introduction Diabetes mellitus is a metabolic disorder characterized by dysregulation and alteration of glucose and lipid metabolism, leading to cognitive impairment. Impaired cognition is caused by a string of risk factors, among which glycemic dysregulation could be a reversible factor. The study aimed to evaluate the effectiveness of melatonin supplementation on impaired cognition in patients with type 2 diabetes mellitus, as assessed by changes in the Montreal Cognitive Assessment (MoCA) score. Method A quasi-experimental design (single-blinded) was conducted with a once-daily tablet of oral melatonin 5 mg at night for three months versus a placebo given in a cohort of 154 patients with type 2 diabetes mellitus after exclusion of a prior major neurological disorder. Patients having a mild to moderate cognitive impairment diagnosed via a validated tool, MoCA, with scores ranging from 10 to 25, were randomly assigned to two treatment groups (melatonin versus placebo). A follow-up at three months was carried out for the cognition scale and biochemical markers (HbA1C, low-density lipoprotein cholesterol (LDL-c), C-reactive protein (CRP), and serum uric acid), and compared with baseline parameters for both groups. Results A total of 154 subjects with a mean (SD) age of 49.98±10.08 years, a mean (SD) HbA1C of 9.49±1.50, and 90 (58.4%) female participants were allocated into two groups, i.e., Melatonin and Placebo. At 12 weeks of treatment, the melatonin-treated group showed…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 154 participants or records.
Read the paper
Related studies
- Tryptophan Metabolism and Gut-Brain Homeostasis
- Rationale for a Multi-Factorial Approach for the Reversal of Cognitive Decline in Alzheimer’s Disease and MCI: A Review
- Prioritized Research for the Prevention, Treatment, and Reversal of Chronic Disease: Recommendations From the Lifestyle Medicine Research Summit
- Relationship between sleep disorders and gut dysbiosis: what affects what?
- The role of CLOCK gene in psychiatric disorders: Evidence from human and animal research
- Genetic, Transcriptome, Proteomic, and Epidemiological Evidence for Blood-Brain Barrier Disruption and Polymicrobial Brain Invasion as Determinant Factors in Alzheimer’s Disease
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.