Study on the Effects and Safety of Nicotinamide for Patients with Type 2 Diabetes and Liver Fibrosis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called nicotinamide in patients who have both type 2 diabetes and liver fibrosis. Type 2 diabetes is a condition where the body struggles to manage blood sugar levels, while liver fibrosis involves the thickening and scarring of liver tissue. The purpose of the study is to evaluate how effective and safe nicotinamide is for these patients. Nicotinamide is a form of vitamin B3 and will be taken orally as part of the treatment.

Participants in the study will be randomly assigned to receive either nicotinamide or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for 12 months, during which various health measurements will be taken to assess changes in liver health and other related factors.

Throughout the study, researchers will monitor changes in liver stiffness, the amount of fat in the liver, and other health indicators. These measurements will help determine if nicotinamide can improve liver health and manage symptoms of type 2 diabetes. The study aims to provide valuable insights into the potential benefits of nicotinamide for patients with these conditions.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, diagnosis of non-alcoholic steatohepatitis (NASH), body mass index (BMI), type 2 diabetes mellitus, and specific liver function tests.

A Fibroscan® test will be performed to measure liver stiffness, and an ELF test will be conducted to assess liver fibrosis.

2 randomization

Participants will be randomly assigned to receive either the study medication, nicotinamide, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

3 medication administration

The study medication, nicotinamide, will be taken orally. The dosage and frequency will be provided by the study team. The treatment will last for a duration of 12 months.

4 regular follow-up visits

Participants will attend regular follow-up visits at 3, 6, and 12 months. During these visits, various assessments will be conducted, including measurements of liver stiffness, intrahepatic fat, and body adiposity.

Blood samples will be collected to analyze changes in circulating levels of substances related to inflammation and metabolism.

5 final assessment

At the end of the 12-month period, a final assessment will be conducted. This includes repeating the Fibroscan® and ELF test to evaluate changes in liver condition.

If applicable, a liver biopsy may be performed to assess histological changes.

Who Can Join the Study?

Patients must be aged between 18 and 85 years.
Must have a diagnosis of NASH (Non-Alcoholic Steatohepatitis) by their doctor. This means having liver fat without significant alcohol use and ruling out other liver diseases.
Body Mass Index (BMI) must be between 30-40 kg/m². BMI is a measure of body fat based on height and weight.
Must have type 2 diabetes mellitus diagnosed by their doctor.
Must have a Fibroscan® value higher than 8 kPa. Fibroscan is a test that measures liver stiffness.
Must have an ELF test result greater than 7.7. The ELF test is a blood test that helps assess liver fibrosis.

Who Cannot Join the Study?

Patients with any other serious liver disease besides hepatic fibrosis (a condition where the liver becomes scarred).
Patients who have had a recent heart attack or stroke.
Patients with uncontrolled high blood pressure.
Patients with severe kidney disease.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with a history of alcohol or drug abuse.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hqdsqgag Di Lh Srifz Ceji I Sqak Pwx	Barcelona	Spain
Hshvtemq Uyaauuuiovtcq Hmewwasr Tnzvz y Pdgodi Iyigiwsv Ceikaf dkqabrxfwqcccabxd (vadb	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Nicotinamide

Nicotinamide is a form of vitamin B3 that is being studied for its potential benefits in people with type 2 diabetes and liver fibrosis. In this trial, researchers are looking at how nicotinamide might help improve liver health and manage blood sugar levels in patients. The goal is to see if it can reduce liver damage and improve overall health in people with these conditions.

Investigated diseases:

Hepatic fibrosis

Hepatic fibrosis – Hepatic fibrosis is a condition characterized by the excessive accumulation of extracellular matrix proteins, including collagen, in the liver. This process occurs as a response to chronic liver injury, often due to factors such as viral hepatitis, alcohol abuse, or non-alcoholic fatty liver disease. Over time, the liver tissue becomes increasingly scarred, which can disrupt normal liver function. The progression of hepatic fibrosis can lead to the development of cirrhosis, where the liver becomes severely scarred and its ability to function is significantly impaired. The condition progresses through various stages, starting from mild fibrosis to more severe forms, depending on the extent and duration of liver damage. Monitoring liver stiffness and changes in liver tissue can help assess the progression of fibrosis.

Trial ID:

2023-504100-28-00

Protocol code:

IIBSP-NIC-2021-157

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of Nicotinamide for Patients with Type 2 Diabetes and Liver Fibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?