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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus in Obese; Dyslipidemia Associated With Type II Diabetes Mellitus
• Intervention / Treatment: Drug: Chinese herb medicine

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).

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited Department of Endocrinology, Guang'anmen Hospital, from January 2015 to December 2020.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational group	Drug: Chinese herb medicine; Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline HbA1c at 3 months, 6 months	0 month, 3 months, 6 months
Changes from Baseline Fasting Blood Glucose at 3 months, 6 months	0 month, 3 months, 6 months
Changes from Baseline Low Density Lipoprotein at 3 months, 6 months	0 month, 3 months, 6 months
Changes from Baseline Triglyceride at 3 months, 6 months	0 month, 3 months, 6 months
Changes from Baseline Body Mass Index at 3 months, 6 months	0 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from Postprandial Blood Glucose at 6 months	0 month, 6 months
Changes from Total Cholesterol at 6 months	0 month, 6 months
Changes from High Density Lipoprotein at 6 months	0 month, 6 months
Changes from Systolic Blood Pressure at 6 months	0 month, 6 months
Changes from Diastolic Blood Pressure at 6 months	0 month, 6 months

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Jiaxing Tian, PhD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: obesity; type 2 diabetes mellitus; Chinese herbal medicine; dyslipidemias; retrospective review
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Dyslipidemias
• Other Study ID Numbers: 2020-035-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No