Prevalence of NAFLD and Advanced Fibrosis in Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Assessing the Prevalence of Nonalcoholic Fatty Liver Disease and Advanced Fibrosis in Patients With Type 1 Diabetes Using Vibration-Controlled Transient Elastography and Noninvasive Scores

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04595474
• Other study ID #: STUDY00000092
• Status: Active, not recruiting
• Start date: January 14, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes receiving care at Joslin clinic using noninvasive imaging and serum-based methods with the goal of identifying high-risk patients with advanced fibrosis who should be prioritized for specialty referral

Description:

This is a prospective cohort, single-center, single-arm study screening adult subjects with type 1 diabetes from the Joslin Diabetes Center outpatient clinic mainly through physician referrals for NAFLD and advanced fibrosis. Subjects will undergo a one-time screening which will last for about 30 minutes.

The following procedures will be conducted during the study visit:

1. Blood draw for metabolic measurements (HbA1c, lipid panel, ALT, AST, serum albumin, complete blood count-CBC)

2. FibroScan Measurements (LSM and CAP)

3. Anthropometric measurements (weight, height, BMI calculation, waist, and hip circumference)

4. Systolic and diastolic blood pressure

Blood Draw:

Samples of blood taken during the trial for laboratory testing will include the following metabolic measurements: AST, ALT, Platelets, percentage A1C, and lipid parameters (TC, LDL, HDL, TG).

Fibroscan: Vibration controlled transient elastography (VCTE) or FibroScan® (EchoSens, Paris, France) is a simple aid to diagnose adult patients with chronic liver diseases. FibroScan provides a fast and reliable alternative to hepatic needle biopsy. In this 5-7 minute test, the investigator induces a mild amplitude shear wave into liver tissue from a small mechanical vibrator at the end of the FibroScan probe. VCTE evaluates a representative volume of the liver that is 100-fold greater than needle biopsy and the liver stiffness measurement (LSM) is expressed in kilopascals (kPa) with values >9.8 kPa being consistent with the presence of advanced fibrosis/cirrhosis. Typically, 10 successful VCTE measurements with a median interquartile range/median ration of less than 30% are needed to have a reliable LSM.

FIB-4 Index: This is a noninvasive surrogate biomarker of advanced fibrosis that is calculated using the following formula:

FIB-4 = Age (years)×AST (U/L)/[PLT(109/L)×√ALT(U/L)] (Sterling, Lissen et al. 2006) FIB-4>2.67 is consistent with the presence of advanced fibrosis with 80% PPV.

NAFLD Fibrosis Score (NFS): This is a noninvasive surrogate biomarker of advanced fibrosis that is calculated using the following formula:

NFS= -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).

NFS>0.676 is consistent with the presence of advanced fibrosis

Anthropometric measurements: These include weight, height, BMI calculation, waist, and hip measurements. Measurements will be done using standardized anthropometric techniques.

Follow up may be required for High-risk patients with advanced fibrosis. If patient consents, referring or treating physicians will be notified and provided with fibroscan results for possible referral to hepatologists for further evaluation and intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 533
• Est. completion date: December 30, 2024
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject is male or female

2. Subject age between 18-75 years old

3. Subject with an established diagnosis of T1D for at least three months prior to screening

Exclusion Criteria:

1. Subject is pregnant or lactating

2. Subject has an active malignancy

4.Subject with secondary causes of fatty liver including history of any of the following:

• Hepatitis B or C virus infection

• Wilson's disease

• Lipodystrophy

• Abetalipoproteinemia

• Current or previous use of any of the following medication: amiodarone, tamoxifen, methotrexate,corticosteroids (e.g. Prednisone), or Valproate

• Male subject consuming >30 g of alcohol per day or female subject consuming >20 g of alcohol perday

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fatty Liver
• Fibrosis
• Fibrosis, Liver
• Liver Cirrhosis
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis
• Type 1 Diabetes

Intervention

Device:
• Transient Elastography
Transient elastography is a noninvasive imaging modality used to assess NAFLD and advanced fibrosis

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with NAFLD	Controlled Attenuation Parameter (CAP) will be used to define the presence of NAFLD	Baseline (one time point evaluation)
Primary	Proportion of subjects with advanced fibrosis	Transient elastography will be used to define the presence of fibrosis	Baseline (one time point evaluation)
Secondary	Proportion of subjects with advanced fibrosis per NAFLD fibrosis score-NFS	NFS will be calculated using the following formula: NFS= -1.675 + 0.037 - age (years) + 0.094 - BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/l) - 0.66 × albumin (g/dl).	Baseline (one time point evaluation)
Secondary	Proportion of subjects with advanced fibrosis per Fibrosis-4 (FIB-4) index	FIB-4 will be calculated using the following formula: FIB-4 = Age (years)×AST (U/L)/[PLT(109/L)×vALT(U/L)]	Baseline (one time point evaluation)
Secondary	HbA1c	Association with level of diabetes control as reflected in percentage HbA1c	Baseline (one time point evaluation)
Secondary	Anthropometrics	Association with BMI and waist circumference	Baseline (one time point evaluation)
Secondary	Lipid profile	Association with lipid parameters (LDL, HDL, TG)	Baseline (one time point evaluation)