Lifestyle Modification for MAFLD Based on TTM

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    75
  • sponsor
    Nanfang Hospital of Southern Medical University
Updated on 13 May 2021

Summary

Lifestyle changes aiming at weight loss remain the cornerstone of MAFLD treatment.Evaluating the motivational stage of patients' change and providing targeted lifestyle guidance may significantly improve the efficiency of weight loss. The investigators hypothesize that gut microbiota may affect motivation to lose weight, and the changes in gut microbiota due to weight loss may positively feedback the behavior of motivation, forming a virtuous circle. Thus, this study aims at evaluating the relationships between motivational stage of weight loss and the gut microbiota (Gut-brain axis); investigating the effects of lifestyle interventions on the gut microbiota in MAFLD patients.

Description

Fatty liver associated with metabolic dysfunction is common, affects a quarter of the population, and has no approved drug therapy. In 2020, two position articles have proposed not only the change of the terminology from NAFLD to metabolic associated fatty liver disease (MAFLD), but also an update and revision of the definition of fatty liver disease. According to these papers, indeed, the diagnosis of MAFLD can be made with the presence of hepatic steatosis (detected by serum biomarker scores, imaging methods or histology) and at least one of the fol- lowing metabolic criteria: (a) overweight/obesity, (b) T2DM and (c) metabolic dysregulation (that means at least two factors among increased waist circumference, hypertension, hypertriglyceridemia, low serum HDL-cholesterol levels, impaired fasting glucose, homeostatic model assessment of insulin resistance [HOMA-IR] > 2.5 or high sensitivity C-reactive protein > 2 mg/L). Herethe investigators focus on the obese NAFLD, which considered as a sub-phenotype in MAFLD.

Lifestyle changes aiming at weight loss remain the cornerstone of MAFLD treatment. However, it is not easy to make patients change their unhealthy lifestyle. Behavior therapy may only be successful in motivated patients, and motivation to dieting and exercising may be different according to age and sex. Personal motivation for change plays a pivotal role in behavior changes. The transtheoretical model (TTM) is an empirically validated model of individual behavioral change, which involves progress through a series of stages to make a particular behavioral change. TTM-based interventions have been applied to facilitate health behavioral changes, such as physical exercise, smoking cessation, and weight management, studies of which continue to demonstrate positive effects. Evaluating the motivational stage of patients' change and providing targeted lifestyle guidance may significantly improve the efficiency of weight loss. The investigators hypothesize that gut microbiota may affect motivation to lose weight, and the changes in gut microbiota due to weight loss may positively feedback the behavior of motivation, forming a virtuous circle.

Thus, a total of seventy obese patients with NAFLD will be recruited in this study, divided into lifestyle modification program group(n=35) and usual care group(n=35). All subjects will undergo dietary assessment based on Food Frequency Questionnaire ( FFQ) and motivational stages evaluation based on TTM. Stool samples will be collected at each visit. Demographic data will be recorded, consisted of age, weight, height, waist circumference, BMI, and so on. MRI-PDFF will be performed to evaluate liver steatosis. Meanwhile, vibration-controlled transient elastography will be carried out, which include liver stiffness (LSM) and controlled attenuation parameter (CAP) measurements. Biochemistry tests will be conducted as supplementary for assessment of NAFLD and cardiovascular risks, comprising liver function test, lipid, fasting glucose, etc.

The investigators aim at evaluating the relationships between motivational stage of weight loss and the gut microbiota (Gut-brain axis); investigating the effects of lifestyle interventions on the gut microbiota in MAFLD patients.

Details
Condition Metabolic Associated Fatty Liver Disease
Treatment Dietitian led life style modification intervention, Conventional care (control)
Clinical Study IdentifierNCT04871880
SponsorNanfang Hospital of Southern Medical University
Last Modified on13 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

With age range of 18-65 years
BMI 28kg/m2
Fatty infiltration of the liver was confirmed on imaging studies (ultrasound, transient elastography, computed tomography, or magnetic resonance imaging) or liver biopsy
With valid motivational stage assessment based on TTM
Written consent form obtained

Exclusion Criteria

History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and Inherited metabolic liver diseases) and hemochromatosis
Self-reported HIV-positive status, active tuberculosis, active malaria, or inflammatory bowel disease
Excessive alcohol consumption (>30g/d for men and >20g/d for women)
Patient has known cirrhosis (compensated/decompensated) either based on clinical criteria or liver histology or Imaging techniques
Subjects using thyroid hormones, oestrogens, amiodarone, steroids, tamoxifen and other medicine known to affect liver fat accumulation
Subjects using thiazolidinedione hypoglycemic drugs, vitamin E and other medicine have potential benefits for NASH within six months
Subjects with organ failure
Subjects with hepatocellular carcinoma or other active malignancy
Solid organ transplant recipients
Antibiotic treatment within the previous 3 months
Suffering from any acute or chronic cardiovascular, GI or immunological condition
Gastric or duodenal ulcer in the past six months
Currently pregnant or nursing
Concomitant diseases with reduced life expectancy
Combined mental illness
Contraindication to MRI scanning
Exclusions may also be made at the discretion of the attending physician or the eligibility committee
Inability to provide informed consent
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note