An observational study in Type2 Diabetes, Fatty Liver, Nonalcoholic and Liver Fibrosis, sponsored by Shen Qu. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by Shen Qu · Observational
Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. The investigators aimed to explore the association between serum PRL and the risk of MAFLD in patients with type 2 diabetes (T2DM).
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 150 across 359 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Shen Qu is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Patients with T2DM who met the inclusion and criteria criteria were consecutively enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: non-invasive method, Fibroscan
Other: non-invasive method, Fibroscan
Other: non-invasive method, Fibroscan
Liver Ultrasound and transient elastography (FibroScan®)
Diagnosis of MAFLD proposed by the international expert consensus statement in 2020
MAFLD was diagnosed based on evidence of ultrasonically diagnosed hepatic steatosis in addition to one of the three criteria proposed by the international expert consensus statement in 2020, namely overweight/obesity, T2DM, or metabolic dysregulation regardless of alcohol consumption or other concomitant liver diseases. Metabolic dysregulation was defined by the presence of at least two metabolic risk abnormalities found in lean or normal weight patients, including hypertension, dyslipidemia, hyperglycemia, IR, and high CRP levels.
Time frame: 2019-2024
PRL
serum prolactin levels
Time frame: 2019-2024
High PRL (HP)
HP was defined as serum PRL ≥ 324mIU/L in males or ≥ 496mIU/L in females according to the normal reference value of serum PRL in our hospital.
Time frame: 2019-2024
Normal PRL (NP)
NP was defined as serum PRL \< 324mIU/L in males or \< 496mIU/L in females.
Time frame: 2019-2024
Diagnosis of hepatic steatosis
Those who have hepatic steatosis if CAP value ≥ 248 dB/m, which was obtained from transient elastography (FibroScan®) using the M probe or the XL probe.
Time frame: 2019-2024
Diagnosis of significant hepatic fibrosis
those who have significant hepatic fibrosis if LSM ≥ 7.0 kPa and ≥ 6.2 kPa (using either M or XL probes)
Time frame: 2019-2024
Homeostasis model assessment of IR (HOMA-IR)
HOMA-IR was calculated as described by Matthews et al: FPG (mmol/L) × FINS (mU/L) /22.5.
Time frame: 2019-2024
Hypertension
it was defined by blood pressure ≥130/85mmHg or antihypertensive drugs.
Time frame: 2019-2024
Dyslipidemia
it was defined by plasma TG ≥ 1.7mmol/L in the total population or plasma HDL-C \< 1.0 mmol/L for men and \< 1.3 mmol/L for women, or specific drug treatment.
Time frame: 2019-2024
Overweight or obesity
it was defined as BMI ≥ 23 kg/m2 in Asians.
Time frame: 2019-2024
Abdominal obesity
It was diagnosed when WC ≥ 90/80 cm in Asian men and women.
Time frame: 2019-2024
T2DM
it was diagnosed according to the guideline for the prevention and treatment of T2DM in China (2020 edition)
Time frame: 2019-2024
High CRP
plasma CRP \> 2 mg/L
Time frame: 2019-2024
High HOMA-IR
HOMA-IR≥ 2.5
Time frame: 2019-2024
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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