Skip to content

Metabolomics and clinical evaluation of Jiedu Tongluo Tiaogan Decoction in the treatment of type 2 diabetes mellitus combined with nonalcoholic fatty liver disease

Metabolomics and clinical evaluation of Jiedu Tongluo Tiaogan Decoction in the treatment of type 2 diabetes mellitus combined with nonalcoholic fatty liver disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005310
Enrollment
Unknown
Registered
2021-09-15
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus combined with nonalcoholic fatty liver disease

Interventions

control group:Conventional western medicine treatment
Experimental group:Conventional western medicine treatment

Sponsors

Shenzhen Hospital of Guangzhou University of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) All the patients meet the diagnostic criteria for type 2 diabetes and non-alcoholic fatty liver disease, and HbA1c is less than 10%. (2) Aged between 20-75 years; (3) Liver function is basically normal: AST or ALT < 2.5 times the upper limit of normal, and total bilirubin was normal; (4) The experimental group did not receive oral treatment of diabetes or non-alcoholic fatty liver at least 2 weeks before admission. The control group did not use hypoglycemic drugs or drugs for the treatment of nonalcoholic fatty liver at least 3 days before joining the group; The effects of drugs on metabolism were excluded. (5) All experimental personnel voluntarily participated in the clinical study, signed informed consent and have good compliance.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the diagnostic criteria and inclusion criteria; (2) Those who cannot carry out the experiment according to the research procedures, including patients with chronic diseases such as cardiovascular and cerebrovascular diseases and mental diseases; (3) Patients treated with insulin; (4) Patients whose condition changes make it difficult to evaluate the effectiveness and safety of the intervention, such as those with severe liver and kidney dysfunction; (5) Allergic constitution or uncomfortable symptoms after taking drugs or a history of drug allergy; (6) Pregnant and lactating women; (7) Patients who participated in other clinical studies in recent 3 months. If any one of the above items is met, it shall not be selected.

Design outcomes

Primary

MeasureTime frame
2hPG;untargeted metabolomics;glycosylated hemoglobin;serum lipids;fasting blood sugar;

Secondary

MeasureTime frame
Fatty liver grade and disease activity index score;visceral fat;TCM syndrome score;

Countries

China

Contacts

Public ContactChunli Piao

Shenzhen Hospital of Guangzhou University of traditional Chinese medicine

pcl2013@sina.cn18819075590

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026