Prevalence of NAFLD and Advanced Fibrosis in Patients With Type 1 Diabetes
- Conditions
- Nonalcoholic SteatohepatitisCirrhosis, LiverNonalcoholic Fatty LiverType 1 DiabetesFibrosis, Liver
- Interventions
- Device: Transient Elastography
- Registration Number
- NCT04595474
- Lead Sponsor
- Joslin Diabetes Center
- Brief 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
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 533
- Subject is male or female
- Subject age between 18-75 years old
- Subject with an established diagnosis of T1D for at least three months prior to screening
- Subject is pregnant or lactating
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Cohort Transient Elastography 533 adult subjects with type 1 diabetes with no secondary causes of fatty liver
- Primary Outcome Measures
Name Time Method Proportion of subjects with NAFLD Baseline (one time point evaluation) Controlled Attenuation Parameter (CAP) will be used to define the presence of NAFLD
Proportion of subjects with advanced fibrosis Baseline (one time point evaluation) Transient elastography will be used to define the presence of fibrosis
- Secondary Outcome Measures
Name Time Method Anthropometrics Baseline (one time point evaluation) Association with BMI and waist circumference
Proportion of subjects with advanced fibrosis per Fibrosis-4 (FIB-4) index Baseline (one time point evaluation) FIB-4 will be calculated using the following formula:
FIB-4 = Age (years)×AST (U/L)/\[PLT(109/L)×√ALT(U/L)\]HbA1c Baseline (one time point evaluation) Association with level of diabetes control as reflected in percentage HbA1c
Proportion of subjects with advanced fibrosis per NAFLD fibrosis score-NFS Baseline (one time point evaluation) 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).Lipid profile Baseline (one time point evaluation) Association with lipid parameters (LDL, HDL, TG)
Trial Locations
- Locations (1)
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States