Characterization and Mechanism Research of the Pre-disease State of Obese Type 2 Diabetes Mellitus

NCT ID: NCT06495814

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-12-30

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.

Conditions

Obese Impaired Glucose Tolerance; Newly Diagnosed Obese Type 2 Diabetic Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cross sectional group of newly diagnosed obese type 2 diabetes mellitus

No intervention conducted

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cross section group of healthy individuals

No intervention conducted

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group of high-risk obese impaired glucose tolerance

General lifestyle intervention+1/bag of Jinlida granules, 3 times/day, taken with hot water.

Group Type: EXPERIMENTAL

1/bag of Jinlida granules, 3 times/day, taken with hot water.

Intervention Type: DRUG

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.

Observation group of high-risk obese impaired glucose tolerance

General lifestyle intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Observation group of low-risk obese impaired glucose tolerance

General lifestyle intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cross sectional group and observation group of obese impaired glucose tolerance

General lifestyle intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

1/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.

Intervention Type: DRUG

Other Intervention Names

General lifestyle intervention

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• 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.

• 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

• 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.

• 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.

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fengmei Lian

OTHER

Sponsor Role: lead

Responsible Party

Fengmei Lian

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Fengmei Lian, doctor

Role: CONTACT

694397644@qq.com

13651249262

Other Identifiers

Obese type 2 diabetes mellitus

Identifier Type: -

Identifier Source: org_study_id