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Liver CirrhosisWELCOMENCT05104541

Impact of Weight Loss in Cirrhosis With Obesity and MAFLD

A study testing Weight loss in people with Liver Cirrhosis and Obesity, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Liver Cirrhosis, Obesity
What is being tested?
Weight loss
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteIndia
Study dates
10 Nov 2021to 9 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Dr. Shiv Kumar Sarin, MD, DM, FNA contact

011-46300000

shivsarin@gmail.com

Harshita Tripathi, M.Sc., PDCC contact

011-46300000

tripathiharshita0521@gmail.com

India1 site, 1 recruiting
  • Institute of Liver and Biliary Sciences

    New Delhi, National Capital Territory of Delhi, 110070

    Dr. Shiv Kumar Sarin, MD, DM, FNA, 011-46300000, shivsarin@gmail.com

    Dr. Shiv Kumar Sarin, MD, DM, FNA

    Recruiting

Other trials in India

About this study

Official title: Impact of Weight Loss on Liver Fibrosis in Obese Patients With Cirrhosis

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.

Read the detailed description

Liver disease is one of the main causes of hospital admissions worldwide and the 12th leading cause of mortality in many countries. Among all etiologies (toxic-metabolites, viral, autoimmune, and genetic disorders), nonalcoholic fatty liver disease (NAFLD) features as the most common cause, with increasing prevalence attributed to the epidemic of metabolic syndrome. According to the World Health Organization, in 2014, more than 30% of the United States population were obese and more than 60% overweight. Furthermore, 15% of all Western population and 35% of patients with obesity will develop steatohepatitis (NASH). Hence world over obesity is on a rise, the prevalence of obesity has consistently risen since past four decades in both genders. Indian similar scenario is seen not only in the urban but also in the rural population. This pandemic disease is attributed to both the increased amounts of processed foods high in fructose, sodium, and saturated fats, and the increasingly sedentary lifestyle. Obesity is considered a chronic state of low-grade inflammation, being associated with complications such as metabolic syndrome, type 2 diabetes, hypertension, and cardiovascular disease. It has also been linked with increased risks of certain cancers, such as colon, breast, breast, endometrium, kidney, esophagus, stomach, pancreas, and gallbladder. The combination of obesity, insulin resistance, and NASH is also thought to increase the risk of Hepatocellular Carcinoma (HCC). Most of all obesity in cirrhotics accelerates decompensation plausibly through an increase in portal hypertension. The risk of first clinical decompensation of cirrhosis is approximately three times higher in obese cirrhotics compared to those with normal weight. There are innumerable randomized controlled trials examining the role of various kinds of weight-loss diets and regimens in NAFLD patients, namely Mediterranean diets, Ornish diets, south beach diets, Atkins diets, Zone diet, weight watcher's diets, etc. However, once cirrhosis sets in or is diagnosed the concept of malnutrition akin to undernutrition is the prime consideration in a patient which baffles the physicians. The nutritional guidelines either European Society of Parenteral and Enteral Nutrition (ESPEN) or American Society of Parenteral and Enteral Nutrition (ASPEN) have always focused on a high calorie and a high protein diet in cirrhosis. These guidelines have not even touched upon the topic of obesity in cirrhosis. Moreover, for decades, investigator have been obsessed with the idea of protein restriction in patients with cirrhosis. In the recent past, our attention is drawn towards the other end of the spectrum of malnutrition i.e. obesity, which has been steadily on the rise world over and cirrhotics are no exception. Obesity is associated with poor survival, severe hepatic decompensation, poor post-transplantation outcomes as well as greater difficulty in liver transplantation, and also higher non-response to antiviral therapy in patients with cirrhosis. Hence weight reduction is the standard of care in such patients. A few studies have examined the role of a monitored exercise program including resistance training including cycle ergometric exercises have been shown to favorably change the body composition but none have been done in obese cirrhotics with the aim of weight loss. At the same time, low-calorie and even very-low-calorie ketogenic diets have been tried in obese cirrhosis and published as case series. Based on the magnitude of the problem of obesity in CLD and its detrimental impact on the clinical outcome investigator propose to assess the impact of weight loss with low calorie, high protein diet and moderate physical activity (lifestyle modifications- a non-pharmacological strategy) on liver fibrosis, body composition changes, functional capacity, clinical outcome in obese cirrhotics in this study.

Being tested
Weight loss
Keywords
Obesity, liver disease, nutrition, weight loss, fibrosis.
Medical subject headings
Liver Cirrhosis, Obesity, Liver Diseases, Weight Loss, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight lossOther

    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.

Study groups in NCT05104541
Study groupRoleWhat they receive
Intervention ArmExperimentalIn 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.
Receives: Other: Weight loss

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (14)
  1. Effect of weight loss (10%) in three months on Insulin resistance (HOMA- IR)

    Insulin resistance will be measured at baseline and at 3 months

    Measured: 3 months

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

    Triglyceride levels will be measured at baseline and at 3 months

    Measured: 3 months

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

    Blood sugar levels will be noted at baseline and at 3 months

    Measured: 3 months

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

    Central obesity will be noted at baseline and at 3 months

    Measured: 3 months

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

    High density lipoprotein (HDL)metabolic syndrome will be noted at baseline and at 3 months

    Measured: 3 months

  6. Effect of weight loss (10%) in three months on metabolic syndrome

    Components of metabolic syndrome will be noted at baseline and at 3 months

    Measured: 3 months

  7. Effect of weight loss (10%) in three months on body composition- bio electrical impedance

    Body composition by bioelectrical impedance will be measured at baseline and at the end of three months

    Measured: 3 months

  8. Effect of weight loss (10%) in three months on anthropometric mid arm muscle circumference (MAMC)

    Mid amr muscle circumference (MAMC) will be measured at baseline and at the end of three months

    Measured: 3 months

  9. Effect of weight loss (10%) in three months on anthropometric Mid upper arm circumference (MUAC)

    Mid upper arm circumference (MUAC) will be measured at baseline and at the end of three months

    Measured: 3 months

  10. Effect of weight loss (10%) in three months on anthropocentric tricep fold thickness (TSF)

    Tricep fold thickness (TSF) will be measured at baseline and at the end of three months

    Measured: 3 months

  11. Effect of weight loss (10%) in three months on functional capacity

    Functional capacity will be measured by hand grip dyanamometer at baseline and at the end of three months

    Measured: 3 months

  12. Effect of weight loss (10%) in three months on Pro inflammatory marker- (Tumor Necrosis Factor) TNF-alpha

    Pro inflammatory marker will be noted at baseline and at 3 months

    Measured: 3 months

  13. Effect of weight loss (10%) in three months on Pro inflammatory marker -IL-6

    Pro inflammatory marker will be noted at baseline and at 3 months

    Measured: 3 months

  14. Effect of weight loss (10%) in three months on Anti inflammatory marker -Adiponectin

    Anti inflammatory marker (Adiponectin) will be noted at baseline and at 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start10 Nov 2021
  3. Primary completion9 Nov 2023 (estimated)
  4. Study completion9 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective Study
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05104541
Sponsor's protocol ID
ILBS-Cirrhosis-45
Acronym
WELCOME
Status last verified
Feb 2023
First submitted
3 Oct 2021
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss in people with Liver Cirrhosis and Obesity, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr. Shiv Kumar Sarin, MD, DM, FNA (011-46300000, shivsarin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients with change in liver fibrosis with 10% weight loss in 3 months in an obese patient with CLD. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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