NCT03774511: [PTREC]

Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial

Completed NA Last updated 26 June 2020

What this trial tests

NA trial testing High-Intensity Interval Exercise & Moderate Intensity Interval Exercise in Diabetes in 48 participants. Completed in 10 December 2018.

Timeline

9 July 2017

Primary endpoint
10 August 2018

10 December 2018

Quick facts

Lead sponsor	Ahlia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	9 July 2017
Primary completion	10 August 2018
Estimated completion	10 December 2018
Sites	1 location across Egypt

Drugs / interventions tested

• High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Conditions studied

• Diabetes — all drugs for Diabetes →
• Nonalcoholic Fatty Liver Disease — all drugs for Nonalcoholic Fatty Liver Disease →
• Obesity — all drugs for Obesity →
• Exercise — all drugs for Exercise →

Sponsor

Ahlia University

Who can join

Adults 40 to 60, any sex, with Diabetes or Nonalcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

background: Obesity, diabetes mellitus type II and fatty liver disease combining with low levels of physical activity are prominent health risks for mortality and morbidity. More than 1/3 of the current population is suffering from obesity with a significant proportion to medical complications which can negatively influence their quality of life. These complications comprise alterations of the metabolism of glucose and fat, insulin resistance and diabetes mellitus. Objectives The purpose of this study was to compare between high intensity interval exercise and moderate intensity continuous on diabetic obese patients with NAFLD. Methods: forty-seven diabetic obese individuals with NAFLD were enrolled in this study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention. IHTG and visceral lipids were assessed pre- and post-intervention.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of high-intensity interval and moderate-intensity continuous aerobic exercise on diabetic obese patients with nonalcoholic fatty liver disease: A comparative randomized controlled trial.
   Abdelbasset WK, Tantawy SA, Kamel DM, Alqahtani BA, et al · · 2020 · cited 71× · PMID 32150108 · DOI 10.1097/md.0000000000019471
2. Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis.
   Buzzetti E, Linden A, Best LM, Madden AM, et al · · 2021 · cited 28× · PMID 34114650 · DOI 10.1002/14651858.cd013156.pub2
3. Retracted: Effect of Moderate-Intensity Aerobic Exercise on Hepatic Fat Content and Visceral Lipids in Hepatic Patients with Diabesity: A Single-Blinded Randomised Controlled Trial.
   And Alternative Medicine EC. · · 2023 · PMID 37854275 · DOI 10.1155/2023/9829387
4. Erratum.
   · 2020 · PMID 32925802 · DOI 10.1097/md.0000000000022388