Dataset Information

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

ABSTRACT:

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.

SUBMITTER: El-Kady RR

PROVIDER: S-EPMC8874180 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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

El-Kady Rasha R RR Ali Amani K AK El Wakeel Lamia M LM Sabri Nagwa A NA Shawki May A MA

Therapeutic advances in chronic disease 20220223

<h4>Background</h4>Nicotinamide has been reported to protect against liver steatosis and metabolic imbalances in nonalcoholic fatty liver disease (NAFLD) in animal models.<h4>Objectives</h4>The objective was to investigate the efficacy and safety of nicotinamide supplementation in diabetic NAFLD patients.<h4>Design</h4>This is a prospective randomized controlled open label study.<h4>Methods</h4>Seventy diabetic NAFLD patients were randomly assigned either to the nicotinamide group (<i>n</i> = 35 ...[more]

PMID: 35222903

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Project description:BackgroundLifestyle modification in patients with nonalcoholic fatty liver disease (NAFLD) is key to improving health outcomes. Mobile health technologies may offer potential effective and efficient health care support to facilitate self-management.ObjectiveThis study aims to develop a lifestyle coaching intervention using a mobile app for patients with NAFLD and evaluate physiological and psychological health outcomes for 6 months.MethodsThis study was a randomized controlled trial. The personalized lifestyle coaching intervention using a mobile app was developed through established guidelines and literature reviews. This intervention consisted of information on NAFLD management, diet and physical activity self-monitoring, and coaching sessions based on patient records and SMS text messages. A total of 102 individuals were enrolled in the study and randomly assigned to the intervention group (n=48) or the control group (n=54). The outcomes were improvements in physiological (weight, liver fat score, aspartate aminotransferase, alanine transferase, and gamma-glutamyl transferase) and clinical outcomes (self-management, NAFLD self-management knowledge, self-efficacy, fatigue, depression, and quality of life). Data were analyzed using descriptive analysis and a linear mixed model to test the effects of the intervention.ResultsAll participants completed the study. The mean age of the participants was 48.9 (SD 13.74) years, 38.2% (39/102) were female participants, and 65.7% (67/102) were married. There were no differences in baseline demographic and clinical data between the intervention and control groups. Changes from baseline to 6 months were significant only within the intervention group for weight (P<.001), liver fat score (P=.01), aspartate aminotransferase (P=.03), alanine transferase (P=.002), gamma-glutamyl transferase (P=.04), self-management (P<.001), fatigue (P=.005), depression (P=.003), and quality of life (P<.001). The differences between the 2 groups for the changes over the 6 months were significant in self-management (P=.004), self-management knowledge (P=.04), fatigue (P=.004), depression (P=.04), and quality of life (P=.01). However, the intervention-by-time interaction was significantly effective only for self-management (P=.006) and fatigue (P=.02).ConclusionsNonpharmacological interventions using a mobile app may be effective in improving the physiological and psychological health outcomes of patients with NAFLD.Trial registrationClinical Research Information Service KCT0005549; http://tinyurl.com/y2zb6usy.

Project description:BackgroundThe prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve.ObjectiveWe aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients.MethodsThis prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons.ResultsThe intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean -0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean -0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months.ConclusionsLifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp.

Dataset Information

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

Background

Objectives

Design

Methods

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

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