NCT05072990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 29, 2021

Last Update Submit

September 14, 2023

Conditions

Type 2 Diabetes Mellitus in ObeseDyslipidemia Associated With Type II Diabetes Mellitus

Keywords

type 2 diabetes mellitusdyslipidemiasobesityChinese herbal medicineretrospective review

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

Observational group

Drug: Chinese herb medicine

Interventions

Chinese herb medicineDRUG

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

Observational group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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;
  • Received 6 months of continuous Chinese herbal medicine treatment;
  • During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
  • 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.
  • Aged 18 to 80 years at the time of their consent;
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2DyslipidemiasObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jiaxing Tian, PhD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Department of Endocrinology

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 11, 2021

Study Start

October 27, 2021

Primary Completion

April 30, 2022

Study Completion

May 15, 2022

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

CN(1)