The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Medical University Union Hospital

About this trial

To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease

Eligibility criteria

Qualifiers

(1) Type 2 diabetes diagnosed according to WHO diagnostic criteria, age ≥ 18 years old, ≤ 70 years old, gender unlimited (2) Diagnosed with NAFLD according to the criteria of the "Guidelines for the Prevention and Treatment of Non alcoholic Fatty Liver Disease (2018 Updated Edition)" (3) Before screening, patients with type 2 diabetes who were treated with single or combined drugs of stable dose (except TZDs, SGLT2i, GLP-1RA, insulin and GKAs) for ≥ 8 weeks and had poor blood glucose control, 7% ≤ HbA1c ≤ 10% (4)BMI≥24 kg/m2 (5) Can understand the content and methods of this study and voluntarily sign an informed consent form

Disqualifiers

Alanine aminotransferase>2.0 times ULN and/or aspartate aminotransferase>2.0 times ULN and/or total bilirubin>2.0 times ULN

Blood ketones>ULN

eGFR <30ml/min/1.73 m2; Note: The formula for calculating eGFR is CKD-EPI (which can be calculated within the WeChat mini program)

Blood creatine kinase>3 times ULN (16) In addition to the above, the researchers have determined that patients who are not suitable to participate in this clinical trial

Trial design

Treatments tested in this trial

  • Addition of Hengge Liejing treatment for 48 weeks

Treatment groups

149 Participants
are divided into 1 treatment group

Locations

This trial has no locations