Newly Diagnosed Obese Type 2 Diabetic Patients, Obese Impaired Glucose Tolerance
Conditions
Brief summary
Establish a comprehensive evaluation system for the progression of obese impaired glucose tolerance (IGT) to type 2 diabetes mellitus (T2DM) through cross-sectional studies; Constructing and validating a T2DM risk prediction model for obese IGT population through observational research; Through open-label clinical research, we applied Jinlida granules to intervene in high-risk obese IGT population and clarify its protective effect on this population.
Interventions
DRUG1/bag of Jinlida granules, 3 times/day, taken with hot water.
All observation and intervention groups received lifestyle interventions, with only the intervention group of high-risk obese impaired glucose tolerance receiving intervention with Jinlida granules.
Sponsors
Fengmei Lian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for obese IGT population: * Age range from 18 to 65 years old, including both ends; * Meet the waist circumference cut-off point for central obesity diagnosis specified in the Guidelines for Primary Diagnosis and Treatment of Obesity (2019); * Meet the IGT diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition); * Voluntarily participate in this study and sign an informed consent form. Inclusion criteria for newly diagnosed obese T2DM population: ① Age range from 18 to 65 years old, including both ends; ② Meet the waist circumference cut-off point for central obesity diagnosis specified in the Guidelines for Primary Diagnosis and Treatment of Obesity (2019); ③ Conform to the T2DM diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition), and the course of disease is less than 3 months; * Voluntarily participate in this study and sign an informed consent form. Inclusion criteria for healthy individuals: * Age range from 18 to 65 years old, including both ends; * Meets the diagnostic criteria for healthy individuals set by WHO; * Voluntarily sign an informed consent form. Inclusion criteria for IGT for high and low-risk obesity: * Age range from 18 to 65 years old, including both ends; * Meet the waist circumference cut-off point for central obesity diagnosis specified in the Guidelines for Primary Diagnosis and Treatment of Obesity (2019); * Meet the IGT diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition); * After screening the risk prediction model constructed in this study, it belongs to the high-risk and low-risk populations with abnormal glucose tolerance; * Voluntarily participate in this study and sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of diabetes | Both the observation group and the intervention group were followed up for 12 months, once a month. | During the follow-up period, when the subjects measured abnormal fasting blood glucose, venous blood was collected and OGTT was measured. Subjects who were diagnosed with type 2 diabetes according to the OGTT results and who were still diagnosed with type 2 diabetes by OGTT one week later were defined as the occurrence of diabetes. |
Contacts
Primary ContactFengmei Lian, doctor
Outcome results
None listed