Obesity combined with type 2 diabetes
Conditions
Interventions
Experimental Group:SangyunYin
Control group:SangyunYin placebo
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) In accordance with the diagnostic criteria of western medicine for T2DM; 2)BMI=24kg/m2 and waist circumference > 85cm for men and > 80cm for women; 3) According to the Constitution Classification and Determination of Traditional Chinese Medicine (TCM) phlegm dampness type constitution was determined; 4) Age 18-65 years old (including boundary value); 5)HbA1C% between 6.5%and 9%; 6) If the duration of diabetes is less than 5 years regular oral non-antidiabetic drug basic treatment is allowed and 0-2 oral antidiabetic drugs are allowed to take regularly for more than 3 months. 7) Patients gave informed consent and were willing to receive corresponding treatment.
Exclusion criteria
Exclusion criteria: 1) Severe cardiovascular and respiratory diseases chronic hypoxemia severe digestive tract diseases gastrointestinal ulcer severe infection and trauma major surgical operation clinical hypotension and hypoxia;The type and extent of serious diseases were determined by the investigators and all those affecting the progress and results of the study were excluded. 2) alanine aminotransferase and serum creatinine >3 times upper limit of normal (ULN); (3) those with uncontrolled or severe mental illness that may affect communication and execution and lead to inaccurate data; 4) women of childbearing age who are pregnant lactating have pregnancy intention or pregnancy test (urine HCG positive); 5) subjects regularly used other diet replacements diet or drugs and related physical therapy within 1 month before enrollment; Those who had weight-loss experience such as fasting dieting injection of GLP1 receptor agonists such as liraglutide in the past 3 months and bariatric surgery; 6) patients with acute complications of diabetes such as ketoacidosis diabetic hyperosmolar syndrome: 7) those who have participated or are participating in other clinical trials within the past 4 weeks; Or taking other hypoglycemic traditional Chinese medicine or western medicine or hypoglycemic food that may have therapeutic effect on T2DM; 8) Allergic to the ingredients of this preparation; 9) Suspected or real history of alcohol or drug abuse or other diseases that may reduce the possibility of enrollment or complicate enrollment according to the investigator's judgment such as frequent changes in work environment and other conditions that may cause loss of follow-up; 10) Persons deemed by the investigator to be ineligible to participate in a clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sugar;Glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electromyography;Metabolomics detection;Urinary microalbumin;Blood lipids;Body fat percentage;BMI;Waist circumference;hip circumference;36-Item Short Form Survey;Measure Yourself Medical Outcomes Profile;Phlegm-Dampness Constitution Conversion Scale;Insulin Assay;C-peptide level; | — |
Countries
China
Contacts
Public Contactweixiong
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed