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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
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051174
Enrollment
Unknown
Registered
2021-09-15
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-01-09

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

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 patients meet the diagnostic criteria of TCM and Western medicine for type 2 diabetes and non-alcoholic fatty liver disease, and HbA1c <= 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 is normal; 4. The experimental group did not take traditional Chinese medicine for diabetes and non-alcoholic fatty liver at least 2 weeks before enrollment; the control group did not use hypoglycemic drugs and drugs for the treatment of non-alcoholic fatty liver at least 3 days before enrollment; excluded drugs Metabolic effects. 5. All experimental personnel voluntarily participated in this clinical study, signed the informed consent, and had good compliance.

Exclusion criteria

Exclusion criteria: 1. Those who cannot conduct experiments in accordance with the research procedures, including patients with chronic diseases such as cardiovascular and cerebrovascular diseases and mental diseases; 2. Patients treated with insulin; 3. Patients with disease changes that make it difficult to evaluate the effectiveness and safety of the intervention, such as those with severe hepatic and renal insufficiency; 4. Allergic constitution or those who have discomfort symptoms or a history of drug allergy after taking drugs; 5. Pregnant and lactating women; 6. Patients who have participated in other clinical studies in the past 3 months.

Design outcomes

Primary

MeasureTime frame
serum lipids;fasting blood sugar;2h postprandial blood glucose;glycosylated hemoglobin;untargeted metabolomics;

Secondary

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

Countries

China

Contacts

Public ContactPiao Chunli

Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine

pcl2013@sina.cn+86 18819075590

Outcome results

None listed

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