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

Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072990
Collaborator
(none)
100
1
6.6
15.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study
Actual Study Start Date :
Oct 27, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Observational group

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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline HbA1c at 3 months, 6 months [0 month, 3 months, 6 months]

  2. Changes from Baseline Fasting Blood Glucose at 3 months, 6 months [0 month, 3 months, 6 months]

  3. Changes from Baseline Low Density Lipoprotein at 3 months, 6 months [0 month, 3 months, 6 months]

  4. Changes from Baseline Triglyceride at 3 months, 6 months [0 month, 3 months, 6 months]

  5. Changes from Baseline Body Mass Index at 3 months, 6 months [0 month, 3 months, 6 months]

Secondary Outcome Measures

  1. Changes from Postprandial Blood Glucose at 6 months [0 month, 6 months]

  2. Changes from Total Cholesterol at 6 months [0 month, 6 months]

  3. Changes from High Density Lipoprotein at 6 months [0 month, 6 months]

  4. Changes from Systolic Blood Pressure at 6 months [0 month, 6 months]

  5. Changes from Diastolic Blood Pressure at 6 months [0 month, 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guang'anmen Hospital, China Academy of Chinese Medical Sciences Beijing Beijing China 100053

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiaxing Tian, Attending Physician, Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT05072990
Other Study ID Numbers:
  • 2020-035-KY
First Posted:
Oct 11, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jiaxing Tian, Attending Physician, Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022