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Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine

Completed
Conditions
Type 2 Diabetes Mellitus in Obese
Dyslipidemia Associated With Type II Diabetes Mellitus
Interventions
Drug: Chinese herb medicine
Registration Number
NCT05072990
Lead Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Brief Summary

This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.

Detailed Description

The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
95
Inclusion Criteria
  1. Meet at least three of the requirements below; 1) Fasting Plasma Glucose > 6.1 mmol/L or 2-hour Postprandial Blood Glucose > 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index > 25 kg / m2; 3) Total Cholesterol > 5.2 mmol / L; Or Triglyceride > 1.70 mmol / L; Or Low-Density Lipoprotein > 3.12 mmol / L; Or High-Density Lipoprotein < 1.04 mmol/L. 4) Systolic blood pressure > 130 mmHg or Diastolic blood pressure > 85 mmHg or diagnosed as hypertension;
  2. Received 6 months of continuous Chinese herbal medicine treatment;
  3. During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
  4. During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
  5. Aged 18 to 80 years at the time of their consent;
  6. Signed informed consent.
Exclusion Criteria
  • Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Observational groupChinese herb medicine-
Primary Outcome Measures
NameTimeMethod
Change from Baseline HbA1c at 3 months, 6 months0 month, 3 months, 6 months
Changes from Baseline Fasting Blood Glucose at 3 months, 6 months0 month, 3 months, 6 months
Changes from Baseline Low Density Lipoprotein at 3 months, 6 months0 month, 3 months, 6 months
Changes from Baseline Triglyceride at 3 months, 6 months0 month, 3 months, 6 months
Changes from Baseline Body Mass Index at 3 months, 6 months0 month, 3 months, 6 months
Secondary Outcome Measures
NameTimeMethod
Changes from Postprandial Blood Glucose at 6 months0 month, 6 months
Changes from Total Cholesterol at 6 months0 month, 6 months
Changes from Systolic Blood Pressure at 6 months0 month, 6 months
Changes from High Density Lipoprotein at 6 months0 month, 6 months
Changes from Diastolic Blood Pressure at 6 months0 month, 6 months

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

🇨🇳

Beijing, Beijing, China

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
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