Clinical trial NCT05072990: Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine
Official title: Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus in Obese
Dyslipidemia Associated With Type II Diabetes Mellitus
Keywords: type 2 diabetes mellitus
dyslipidemias
obesity
Chinese herbal medicine
retrospective review
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited Department of Endocrinology, Guang'anmen Hospital, from January 2015 to December 2020.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline HbA1c at 3 months, 6 months
timeFrame: 0 month, 3 months, 6 months
measure: Changes from Baseline Fasting Blood Glucose at 3 months, 6 months
timeFrame: 0 month, 3 months, 6 months
measure: Changes from Baseline Low Density Lipoprotein at 3 months, 6 months
timeFrame: 0 month, 3 months, 6 months
measure: Changes from Baseline Triglyceride at 3 months, 6 months
timeFrame: 0 month, 3 months, 6 months
measure: Changes from Baseline Body Mass Index at 3 months, 6 months
timeFrame: 0 month, 3 months, 6 months
Secondary outcomes:
measure: Changes from Postprandial Blood Glucose at 6 months
timeFrame: 0 month, 6 months
measure: Changes from Total Cholesterol at 6 months
timeFrame: 0 month, 6 months
measure: Changes from High Density Lipoprotein at 6 months
timeFrame: 0 month, 6 months
measure: Changes from Systolic Blood Pressure at 6 months
timeFrame: 0 month, 6 months
measure: Changes from Diastolic Blood Pressure at 6 months
timeFrame: 0 month, 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiaxing Tian, PhD
role: PRINCIPAL_INVESTIGATOR
References: