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. 2022 Jul 14;77(2):558–572. doi: 10.1002/hep.32620

TABLE 1. Details of participants and methods used in this study.

Lean healthy controls Study 1: patients with severe obesity Study 2: patients with T2DM Study 3: patients screened for liver disease
Derivation n = 10 n = 38 – –
Validation – n = 59 n = 36 n = 75
Inclusion criteria

  • Age 40–75 years

  • Age 18–70 years

  • BMI ≥35 kg/m2

  • Age 18–79 years

  • Diagnosed with T2DM

  • Age 30–75 years
Exclusion criteria (1) Use of prescription drugs, (2) Any chronic disease, (3) Use of antibiotics within 6 months, (4) Alcohol use >8 g for women and 16 g for men per day, (5) Abnormal US and/or elevated TE, (6) Hospital contacts within 6 months. (1) Chronic liver disease other than NAFLDa, (2) Decompensated cirrhosisb, (3) Pregnancy, (4) Severe/deadly illness, (5) Hepatotoxic medicationc, (6) Alcohol use >12 g for women and >24 g for men per dayd, (7) Following low carbohydrate diete, (8) >10 kg weight loss within the last 3 monthse, (9) Use of antibiotics within the last 2 monthse.
Inclusion period May 2016–Mar. 2018 Aug. 2018–ongoing Nov. 2016–Jun. 2021 Oct. 2017–ongoing
Study name and ethics approvalf Gala‐HP S‐20160006G PROMETHEUS S‐20160006G REDUCTION S‐20150217 SIPHON S‐20170087
Registration OPEN.rsyd.dk, OP‐239 ClinicalTrials.gov: NCT03535142 ClinicalTrials.gov: NCT03068078 ClinicalTrials.gov: NCT03308916

Note: Study 3 included patients with alcohol overuse, however, patients with alcohol overuse were excluded in Studies 1 and 2 (see Figure 2, consort diagram).

Abbreviations: BMI, Body Mass Index; OPEN, Odense Patient data Explorative Network; T2DM, type 2 diabetes mellitus; TE, transient elastography; US, ultrasound.

a

Liver biopsy and biochemical results showing evidence of viral hepatitis, autoimmune liver disease, cholestatic liver disease, and/or primary hemochromatosis.

b

Defined as manifestation of ascites, overt hepatic encephalopathy, jaundice, hepatorenal syndrome, or variceal hemorrhage.

c

Tamoxifen, amiodarone, systemic glucocorticoids, and methotrexate.

d

Only Study 1 and 2.

e

Only Study 2.

f

Identifying number from Ethics committee in Region of Southern of Denmark.