Last updated: April 29, 2024
Sponsor: Technische Universität Dresden
Overall Status: Active - Recruiting
Phase
N/A
Condition
Obesity
Metabolic Disorders
Diabetes Prevention
Treatment
Liver Ultrasound
Oral glucose tolerance test
Fibroscan of the Liver
Clinical Study ID
NCT06396871
BO-EK-508112022
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age > 18 years old Additional inclusion criteria for case groups:
- High risk group for significant liver fibrosis
- FIB-4 score ≥ 1.3 AND 2. Fibroscan measurement ≥ 8kPa
- Steatotic Liver Disease group
- Diagnosis of steatosis in ultrasound AND CAP > 275 dB/m
- Prediabetes
- HbA1c >5.7 AND <6.5% OR/AND
- Fasting Glucose 100-125 mg/dl OR/AND
- Glucose at 120 min of OGTT between 140-200 mg/dl
- Diabetes 1. HbA1c ≥ 6.5% OR/AND 2. Fasting Glucose > 126 mg/dl OR/AND 3. Glucose at 120 min of OGTT > 200 mg/dl If a subject does not fulfil the additional criteria for participating in a casegroup, then he/she will be included in the respective control group which will be: A#) Low risk for significant liver fibrosis 1. Fibroscan measurements < 8kPa B#) Nosteatosis group
- No steatosis in liver ultrasound AND CAP ≤ 275 dB/m C#) Normal glucose tolerancetest group
- HbA1c < 5.7% AND
- Fasting glucose < 100 mg/dl AND
- Glucose at 120 min of OGTT <140 mg/dl
Exclusion
Exclusion Criteria:
- Diabetes mellitus Typ 1
- BMI < 18.5 kg/m2
- Transfusion of blood or major bleeding in the last six months
- Anaemia with haemoglobin < 9,0 g/dl
- Chronic alcohol or drug abuse
- Presence of any acute or chronic liver disease apart from non-alcoholic fattyliver disease (i.e. viral, autoimmune or alcoholic hepatitis, haemochromatosis,Morbus Wilson etc.)
- Systemic infections (CRP > 1 mg/dl)
- Medications that affect blood glucose levels (e.g. antidiabetics [except from thesubjects forming the diabetes group], steroids) in the last six months
- Medications that affect coagulation (e.g. anticoagulants and antiplatelet agents)in the last six months
- Medications that affect immune function (e.g. immunosuppressive drugs) in thelast six months
- Pregnancy or breastfeeding
- Severe psychic disorders
- Inability to follow the study protocol
- Have any medical condition unsuitable for inclusion in the study, in the opinionof the investigator Additional exclusion criteria for MRI:
- Pacemaker
- Artificial heart valve
- Metal prosthesis
- Implanted magnetic metal parts
- Spirals
- Fixed metal dental braces
- Acupuncture needle
- Insulin pumps
- By MRI > 3 Tesla: Tattoos, permanent eyeliner
- Claustrophobia or any other condition, such as psychiatric disorder, that in theopinion of the investigator may prevent the participant from following andcompleting the protocol
- Subject dimensions not allowing the performance of MRI
Study Design
Total Participants: 180
Treatment Group(s): 4
Primary Treatment: Liver Ultrasound
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
December 31, 2026
Connect with a study center
University Study Center for Metabolic Diseases
Dresden, Saxony 01307
GermanyActive - Recruiting
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