Clinical trial NCT06495814: Characterization and Mechanism Research of the Pre-disease State of Obese Type 2 Diabetes Mellitus
Official title: Characterization and Mechanism Research of the Pre-disease State of Obese Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obese Impaired Glucose Tolerance
Newly Diagnosed Obese Type 2 Diabetic Patients
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

Exclusion criteria for obese IGT patients:

* The population who have been continuously using hypoglycemic drugs within the past three months;

  * Type 1 diabetes and type 2 diabetes (T2DM), pregnancy diabetes, secondary diabetes and other special types of diabetes;

    * Hyperthyroidism or hypothyroidism caused by endocrine disorders, with poor disease control;

      * Difficult to control hypertension/hypotension: systolic blood pressure ≥ 200mmHg or diastolic blood pressure ≥ 110mmHg; Or systolic blood pressure ≤ 90mmHg or diastolic blood pressure ≤ 60mmHg;

        * When screening, patients with various acute infections, or those accompanied by severe infections, severe anemia, or neutropenia;

          * Accompanied by other major diseases, such as active or untreated malignant tumors, or clinical remission of malignant tumors for less than 5 years;

            * Organic heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, with NYHA heart function grading\>Grade III;

              ⑧ The patient has suffered from any of the following diseases within the past 6 months: coronary intervention (such as CABG or PTCA), stroke (including ischemic and hemorrhagic stroke);

              ⑨ Severe liver and kidney dysfunction (ALT greater than 3 times the upper normal limit, creatinine greater than 132 μ mol/l);

              ⑩ Fasting TG\>5.6mmol/L;

              ⑪ Pregnant and lactating women, as well as women of childbearing age who have not taken effective contraceptive measures;

              ⑫ Participating in any other clinical trials/researchers;

              ⑬ Patients with a history of alcoholism or long-term drug abuse;

              ⑭ Individuals with a history of mental illness are unable to cooperate with the researchers;

              ⑮ For any other reason, the researcher considers it unsuitable to participate in this study.

Exclusion criteria for newly diagnosed obese T2DM patients:

* Type 1 diabetes, gestational diabetes, secondary diabetes and other special types of diabetes;

  * The population who have been continuously using hypoglycemic drugs within the past three months;

    * Patients with complications of diabetes;
    * Hyperthyroidism or hypothyroidism caused by endocrine disorders, with poor disease control;

      * Difficult to control hypertension/hypotension: systolic blood pressure ≥ 200mmHg or diastolic blood pressure ≥ 110mmHg; Or systolic blood pressure ≤ 90mmHg or diastolic blood pressure ≤ 60mmHg;

        * When screening, patients with various acute infections, or those accompanied by severe infections, severe anemia, or neutropenia;

          * Accompanied by other major diseases, such as active or untreated malignant tumors, or clinical remission of malignant tumors for less than 5 years;

            ⑦ Organic heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, with NYHA heart function grading\>Grade III;

            ⑧ The patient has suffered from any of the following diseases within the past 6 months: coronary intervention (such as CABG or PTCA), stroke (including ischemic and hemorrhagic stroke);

            ⑨ Severe liver and kidney dysfunction (ALT greater than 3 times the upper normal limit, creatinine greater than 132 μ mol/l);

            ⑩ Fasting TG\>5.6mmol/L;
            * Pregnant and lactating women, as well as women of childbearing age who have not taken effective contraceptive measures;

              * Patients with a history of alcoholism or long-term drug abuse;

                * Individuals with a history of mental illness are unable to cooperate with the researchers;

                  * Participating in any other clinical trials/researchers;

                    ⑮ For any other reason, the researcher considers it unsuitable to participate in this study.

Exclusion criteria for healthy individuals:

* Any history of chronic diseases of various systems that have been previously diagnosed, such as obesity, endocrine and metabolic diseases, hematopoietic system diseases, respiratory system diseases, cardiovascular system diseases, malignant tumors, liver and kidney dysfunction, etc;

  * When screening, patients with various acute infections, or those accompanied by severe infections, severe anemia, or neutropenia;

    * Patients with a history of alcoholism or long-term drug abuse;

      * Pregnant or lactating women;

        * Individuals with a history of mental illness who cannot cooperate with the research process;

Primary outcomes:
measure: incidence of diabetes
timeFrame: Both the observation group and the intervention group were followed up for 12 months, once a month.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: