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

Joslin Diabetes Center

Status: Active, not recruiting

Conditions: Fibrosis, Liver; Nonalcoholic Fatty Liver; Type 1 Diabetes; Cirrhosis, Liver; Nonalcoholic Steatohepatitis

Treatments: Device: Transient Elastography

Study type: Observational

Funder types: Other

Identifiers

NCT04595474

STUDY00000092

Details and patient eligibility

About

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

Full 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.

Enrollment: 533 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

533 participants in 1 patient group

Study Cohort

Description:

533 adult subjects with type 1 diabetes with no secondary causes of fatty liver

Treatment:

Device: Transient Elastography