Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01997424
  4. Details
NCT01997424 Clinical Trial

Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

Official title:
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01997424
Other study ID # JWGUHMED1-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2013
Est. completion date December 31, 2019

Study information
Verified date February 2021
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination: - Transient Elastography and Controlled Attenuation Parameter using the FibroScan - blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.

Recruitment information / eligibility
Status Completed
Enrollment 340
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female, 18 years and older - Written informed consent - Diabetes mellitus type 1 or 2 Exclusion Criteria: - Patients with mental diseases - Pregnancy or lactation - Ascites - Continued alcohol consumption (> 21 drinks/week for male and > 14 drinks/week for female patients) - Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson) - Hepatocellular carcinoma/ Liver metastasis

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Controlled Attenuation Parameter (CAP), Echosens, Paris, France

• FibroScan, Echosens, Paris, France

Locations
Country Name City State
Germany University Hospital Frankfurt Frankfurt am Main Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Steatosis • Evaluating the presence of liver steatosis in patients with diabetes mellitus using the ultrasound-based method "Controlled Attenuation Parameter", which is integrated in the FibroScan machine and can non-invasively quantify liver steatosis (Steatosis fibrosis scores I-III [ Designated as safety issue: No ]; Steatosis scores: 0 = <5% I = 5-33% II = 33-66% III = >66%) one day
Secondary Fibrosis • Evaluation of the prevalence of liver fibrosis using transientelastography (FibroScan) and serological markers in patients with diabetes mellitus (Liver fibrosis scores I-IV (METAVIR) [ Designated as safety issue: No ]; METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis) one day
Secondary Steatosis (serum) • Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus one day
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04099147 - Diagnosis and Characterization of Non-Alcoholic Fatty Liver Disease Based on Artificial Intelligence.
Completed NCT04019561 - A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. Phase 2
Withdrawn NCT00375349 - Non Alcoholic Fatty Liver Disease Influence of Statin Therapy N/A
Active, not recruiting NCT04682600 - The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF N/A
Terminated NCT02605616 - Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD) Phase 2
Completed NCT04165343 - Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
Recruiting NCT03151473 - Longitudinal Observational Study Of Chinese With NAFLD/NASH
Recruiting NCT04820036 - A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) N/A
Active, not recruiting NCT02037321 - Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk N/A
Completed NCT01110577 - Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171) N/A
Completed NCT00771108 - Exercise Dose and Nonalcoholic Fatty Liver Disease N/A
Recruiting NCT04639414 - Combined Active Treatment in Type 2 Diabetes With NASH Phase 4
Completed NCT04450875 - Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD N/A
Recruiting NCT02654665 - Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults Phase 3
Recruiting NCT05699018 - Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients N/A
Withdrawn NCT02457286 - Improving Insulin Resistance To Treat Non-Alcoholic Fatty Liver Disease: A Pilot Study Phase 1
Withdrawn NCT02194894 - The Effect of Acetaminophen on Non-alcoholic Fatty Liver Disease Patients N/A
Completed NCT01811472 - Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients Phase 2
Completed NCT00968747 - Regulation of FGF21 by Nutritional Challenges N/A
Recruiting NCT04330326 - Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease Phase 2