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

NCT06495814 | Not Yet Recruiting Phase 2

• 1 other identifier: Obese type 2 diabetes mellitus
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• incidence of diabetes

  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.

  Both the observation group and the intervention group were followed up for 12 months, once a month.

Study Arms (6)

Cross sectional group of newly diagnosed obese type 2 diabetes mellitus

NO INTERVENTION

No intervention conducted

Cross section group of healthy individuals

NO INTERVENTION

No intervention conducted

Intervention group of high-risk obese impaired glucose tolerance

EXPERIMENTAL

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

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

Observation group of high-risk obese impaired glucose tolerance

NO INTERVENTION

General lifestyle intervention

Observation group of low-risk obese impaired glucose tolerance

NO INTERVENTION

General lifestyle intervention

Cross sectional group and observation group of obese impaired glucose tolerance

NO INTERVENTION

General lifestyle intervention

Interventions

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

Also known as: General lifestyle intervention

Intervention group of high-risk obese impaired glucose tolerance

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fengmei Lian: lead

Central Study Contacts

Fengmei Lian, doctor

CONTACT

13651249262; 694397644@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 11, 2024
• Study Start: July 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share