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NCT06495814Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 11 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
380 (estimated)
First submitted
2 Jul 2024
Start date
1 Jul 2024
Primary completion date
30 Dec 2025
Lead sponsor
Fengmei Lian
NCT number
NCT06495814

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 380
  • From 1 Jul 2024 to the primary completion date, 30 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.