دورية أكاديمية
أعرض في EDS

Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial.

التفاصيل البيبلوغرافية
العنوان: Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial.
المؤلفون: El-Kady RR; Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt., Ali AK; Department of Internal Medicine, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt., El Wakeel LM; Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt., Sabri NA; Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt., Shawki MA; Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo 11566, Egypt.
المصدر: Therapeutic advances in chronic disease [Ther Adv Chronic Dis] 2022 Feb 23; Vol. 13, pp. 20406223221077958. Date of Electronic Publication: 2022 Feb 23 (Print Publication: 2022).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: SAGE Publications Country of Publication: United States NLM ID: 101532140 Publication Model: eCollection Cited Medium: Print ISSN: 2040-6223 (Print) Linking ISSN: 20406223 NLM ISO Abbreviation: Ther Adv Chronic Dis Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Los Angeles : SAGE Publications
مستخلص: Background: Nicotinamide has been reported to protect against liver steatosis and metabolic imbalances in nonalcoholic fatty liver disease (NAFLD) in animal models.
Objectives: The objective was to investigate the efficacy and safety of nicotinamide supplementation in diabetic NAFLD patients.
Design: This is a prospective randomized controlled open label study.
Methods: Seventy diabetic NAFLD patients were randomly assigned either to the nicotinamide group ( n  = 35) who received nicotinamide 1000 mg once daily for 12 weeks in addition to their antidiabetic therapy or the control group ( n  = 35) who received their antidiabetic therapy only. The primary outcome was improvement in steatosis score, while secondary outcomes included assessment of liver stiffness, liver enzymes, lipid profile, insulin resistance, serum malondialdehyde, serum adiponectin, and patients' quality of life (QOL).
Results: Only 61 patients completed the study; 31 in the nicotinamide group and 30 in the control group. Comparisons between groups and within groups revealed nonsignificant changes in steatosis and fibrosis scores. However, significant reduction was observed in liver enzymes with a median decrease in alanine transaminase of 26.6% versus 0.74% in nicotinamide and control groups, respectively. After 12 weeks of treatment, the nicotinamide group showed significantly lower levels of low-density lipoprotein cholesterol ( p value = 0.004), total cholesterol ( p value = 0.006), and insulin resistance marker ( p value = 0.005) compared with control. Serum triglycerides, malondialdehyde, and adiponectin levels were all comparable between the two groups. Regarding QOL, a significant improvement was detected in the total scores and the activity and fatigue domains scores.
Conclusion: Nicotinamide at a dose of 1000 mg daily was tolerable, improved metabolic abnormalities and QOL of diabetic NAFLD patients with no effect on liver fibrosis or steatosis.
Trial Registration: The study was registered at clinicaltrials.gov and given the ID number: ' NCT03850886 '. https://clinicaltrials.gov/ct2/show/NCT03850886.
Competing Interests: Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
(© The Author(s), 2022.)
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فهرسة مساهمة: Keywords: Fibroscan; nicotinamide; nonalcoholic fatty liver disease; steatosis
سلسلة جزيئية: ClinicalTrials.gov NCT03850886
تواريخ الأحداث: Date Created: 20220228 Latest Revision: 20220502
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC8874180
DOI: 10.1177/20406223221077958
PMID: 35222903
قاعدة البيانات: MEDLINE
الوصف
تدمد:2040-6223
DOI:10.1177/20406223221077958