Type 2 Diabetes Mellitus with Obesity
Conditions
Interventions
control group:Conventional Western medical treatment for diabetes along with lifestyle interventions and a placebo of Keluotong formula granules with a single dose of 10g three times daily orally befo
intervention group:Conventional Western medical treatment for diabetes along with lifestyle interventions and the use of Keluotong formula granules with a single dose of 10g taken three times daily or
Sponsors
Shenzhen Traditional Chinese Medicine Hospital Shenzhen China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for "simple obesity" as proposed by the Chinese Obesity Task Force and the Chinese Diabetes Society excluding other secondary causes with a Body Mass Index (BMI) = 28 kg/m² which can be diagnosed as simple obesity. 2.Meet the diagnostic criteria for type 2 diabetes as outlined in the "China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)": presenting with typical diabetes symptoms such as increased thirst and drinking polyuria polyphagia and unexplained weight loss along with fasting blood glucose = 7.0 mmol/L or 2-hour blood glucose during an Oral Glucose Tolerance Test (OGTT) = 11.1 mmol/L or random blood glucose = 11.1 mmol/L or glycated hemoglobin (HbA1c) = 6.5%. 3.Obesity type 2 diabetes and its syndrome types refer to the relevant content in the "Evidence-Based Clinical Guideline for Traditional Chinese Medicine in the Treatment of Diabetes (2016 Edition)" edited by Professor Tong Xiaolin and published by Science Press. The symptoms for the phlegm-stasis syndrome are as follows: Main symptoms: Overweight body enlarged abdomen dull complexion numbness or pain in the limbs and chest tightness with stabbing pain. Secondary symptoms: Dizziness abdominal bloating heavy head and increased sleepiness. Tongue and pulse: Dark purple lips and tongue blood stasis spots on the tongue or sublingual network thin white coating and a string-like and choppy pulse. Individuals with at least two main symptoms one secondary symptom and matching tongue and pulse characteristics. 4.No history of weight loss medication use prior to enrollment. 5.Age is = 18 years old and < 70 years old. 6.Glycated hemoglobin (HbA1c) = 9% and random blood glucose = 16.7 mmol/L. 7.Not having participated in any interventional clinical studies or trials in the past 3 months. 8.Capable and willing to sign an informed consent form and complete the study.
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes gestational diabetes and other specific types of diabetes; 2) Individuals with severe impairment of liver or kidney function; 3) Thyroid disorders and other conditions that affect carbohydrate metabolism; 4) Acute complications of diabetes within the past month; 5) Acute infections or other stress states within the past month. 6) Individuals deemed ineligible to participate in this study by the investigator due to mental psychological or other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI; | — |
Secondary
| Measure | Time frame |
|---|---|
| FBG;tongue manifestation;CMP;ECG;physical examination;HbA1c;fasting insulin;TCMSSS;WHR;VFA; | — |
Countries
China
Contacts
Public ContactHuilin Li
Shenzhen Traditional Chinese Medicine Hospital Shenzhen China
Outcome results
None listed