Impact of Weight Loss in Cirrhosis With Obesity and MAFLD

NCT05104541 | Unknown DMC

• 1 other identifier: ILBS-Cirrhosis-45
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Nutrition therapy is the cornerstone of medical therapy in patients with cirrhosis. 70% compensated patients with Chronic Liver Disease (CLD) are overweight or obese. Obesity in CLD augments decompensation, plausibly through increase in portal pressure. Moreover, the cardiometabolic risk factors are increased with increase in body weight, obesity also has an impact on the already compromised health-related quality of life of patients with CLD. Most feasible, safe, and widely used method of management of obesity is life-style modifications. Hypocaloric with normal to high protein diet along with moderate-intensity exercises have been practiced for weight reduction. These kinds of dietary changes reduce body weight and may bring about favourable changes in the body composition (reduce the body fat percentage but at the same time preserving the lean body mass). Weight loss in obese patients with CLD would in turn improve the clinical outcome, reduce the hepatic complications, moreover weight loss may also improve health related quality of life, and other prognostic markers of the disease like fibroscan along with improvement in the associated metabolic derangements in patients with CLD. There is no Indian data in this context. Thus, through this trial, investigator would be able to ascertain an appropriate lifestyle-related non- intervention regimen that helps in the management of obesity in patients with cirrhosis. Not only that the baseline information of these obese patients with CLD would give us an idea or the profile of the body composition in terms of muscularity, adiposity, sarcopenic obesity (if any), of these patients with CLD.

Conditions

Liver Cirrhosis; Obesity

Keywords

Obesity; liver disease; nutrition; weight loss; fibrosis.

Outcome Measures

Primary Outcomes (1)

• Number of Patients with change in liver fibrosis with 10% weight loss in 3 months in an obese patient with CLD.

  3 months

Secondary Outcomes (14)

• Effect of weight loss (10%) in three months on Insulin resistance (HOMA- IR)

  3 months

• Effect of weight loss (10%) in three months on Triglyceride levels

  3 months

• Effect of weight loss (10%) in three months on blood sugar levels as a component of metabolic syndrome

  3 months

• Effect of weight loss (10%) in three months on central obesity as a component of metabolic syndrome

  3 months

• Effect of weight loss (10%) in three months on high density lipoprotein (HDL) as a component of metabolic syndrome

  3 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

In addition to standard pharmacological treatment this group would receive diet comprising of 20-25 kcal and 1.2gm protein per kg ideal body weight per day. The total distribution of the calories would be as 55-60% from carbohydrates, 25% from protein, and 20% from fat. The diet would be explained to the patient with the help of individual diet charts.

Other: Weight loss

Interventions

Weight loss OTHER

In addition to standard pharmacological treatment this group would receive diet comprising of 20-25 kcal and 1.2gm protein per kg ideal body weight per day. The total distribution of the calories would be as 55-60% from carbohydrates, 25% from protein and 20% from fat. The diet would be explained to the patient with the help of individual diet charts.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients between 18 and 65 years.
• Obese cirrhotics of any etiology.
• BMI \> 30

You may not qualify if:

• Patients with oChild B (8,9) and C oMELD\>20
• High-risk varices
• HPS/ pleural effusion
• Alcoholic Hepatitis
• Chronic Kidney Disease, cardiac, neurological diseases
• HCC
• Pregnancy
• Unwilling patients

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Obesity; Liver Diseases; Weight Loss; Fibrosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes

Study Officials

• Dr. Shiv Kumar Sarin, MD, DM, FNA

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shiv Kumar Sarin, MD, DM, FNA

CONTACT

011-46300000; shivsarin@gmail.com

Harshita Tripathi, M.Sc., PDCC

CONTACT

011-46300000; tripathiharshita0521@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Study

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: November 3, 2021
• Study Start: November 10, 2021
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

IN (1)