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

Type 2 Diabetes Mellitus in Obese Clinical Trial

Official title:

Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072990
• Other study ID #: 2020-035-KY
• Status: Completed
• Start date: October 27, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: September 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 15, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia Associated With Type II Diabetes Mellitus
• Dyslipidemias
• Obesity
• Type 2 Diabetes Mellitus in Obese

Intervention

Drug:
• Chinese herb medicine
Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HbA1c at 3 months, 6 months		0 month, 3 months, 6 months
Primary	Changes from Baseline Fasting Blood Glucose at 3 months, 6 months		0 month, 3 months, 6 months
Primary	Changes from Baseline Low Density Lipoprotein at 3 months, 6 months		0 month, 3 months, 6 months
Primary	Changes from Baseline Triglyceride at 3 months, 6 months		0 month, 3 months, 6 months
Primary	Changes from Baseline Body Mass Index at 3 months, 6 months		0 month, 3 months, 6 months
Secondary	Changes from Postprandial Blood Glucose at 6 months		0 month, 6 months
Secondary	Changes from Total Cholesterol at 6 months		0 month, 6 months
Secondary	Changes from High Density Lipoprotein at 6 months		0 month, 6 months
Secondary	Changes from Systolic Blood Pressure at 6 months		0 month, 6 months
Secondary	Changes from Diastolic Blood Pressure at 6 months		0 month, 6 months