Research for effect and mechanism of HanTangping VS Metformin treatment of newly diagnosed type 2 diabetes: a randomized controlled trial

Phase 1

Recruiting

• Conditions: Type 2 diabetes

• Registration Number: ITMCTR1900002364
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Those who meet the diagnostic criteria of Western medicine and the diagnostic criteria of TCM syndromesand:
1. Aged 18 to 60 years;
2. Diagnosed as type 2 diabetes, who had not received any hypoglycemic medication in the past and who had poor control of blood glucose after 3 months of dietary exercise or had short-term hypoglycemic medication (<1 month) and discontinued for more than 3 months.
3. Islet function is acceptable, insulin release test shows delayed insulin secretion or insulin peak / basal value = 3 (Ip / Io = 3).
4. 18kg/m2=BMI=35kg/m2.
5. Voluntary participants in the study and signed informed consent.

Exclusion Criteria

1. Although the blood glucose is higher than normal, the blood glucose test drops below the diagnostic value through the diet control and the increase in the activity during the test introduction phase.
2. Pregnancy or lactation women.
3. People who cannot take metformin.
4. Those who are allergic to traditional Chinese medicine ingredients.
5. People with serious heart, liver, kidney, brain and other complications or other serious primary diseases.
6. People with acute metabolic disorders such as diabetic ketoacidosis or co-infection in the past 1 month.
7. People who are unwilling to cooperate or mentally ill.
8. People with diabetes complications as the main symptom

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin;

Secondary Outcome Measures

Name	Time	Method
HOMA-ß;Total cholesterol;HOMA-IR;2-hour postprandial blood glucose;Body fat rate;Area under the insulin curve;electrocardiogram;renal function;Fasting plasma glucose;Fiery symptom score;routine urinalysis;routine blood tests;Low density lipoprotein cholesterol;Symptom grading quantization table;Triglyceride;Complication rate;liver function;High density lipoprotein cholesterol;