Obese Impaired Glucose TolerancePhase 2NCT06495814

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

A Phase 2 study testing 1/bag of Jinlida granules, 3 times/day, taken with hot water. in people with Obese Impaired Glucose Tolerance and Newly Diagnosed Obese Type 2 Diabetic Patients, run by Fengmei Lian.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obese Impaired Glucose Tolerance, Newly Diagnosed Obese Type 2 Diabetic Patients
What is being tested?: 1/bag of Jinlida granules, 3 times/day, taken with hot water.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: No sites listed yet
Study dates: 1 Jul 2024to 30 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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;

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fengmei Lian, doctor contact

13651249262

694397644@qq.com

About this study

Conditions: Obese Impaired Glucose Tolerance, Newly Diagnosed Obese Type 2 Diabetic Patients
Being tested: 1/bag of Jinlida granules, 3 times/day, taken with hot water.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06495814
Study group	Role	What they receive
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202430 Dec 2026

First posted11 Jul 2024
Study start1 Jul 2024 (estimated)
Primary completion30 Dec 2025 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obese Impaired Glucose ToleranceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 380 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06495814
Sponsor's protocol ID: Obese type 2 diabetes mellitus
Status last verified: Jul 2024
First submitted: 2 Jul 2024
Last updated: 11 Jul 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization and Mechanism Research of the Pre-disease State of Obese Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT06495814
Acronym / sponsor ID: Obese type 2 diabetes mellitus
Conditions: Obese Impaired Glucose Tolerance, Newly Diagnosed Obese Type 2 Diabetic Patients
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 380 participants (estimated)
Lead sponsor: Fengmei LianUniversity, hospital or other
Study start: 1 Jul 2024 (estimated)
Primary completion: 30 Dec 2025 (estimated)
Study completion: 30 Dec 2026 (estimated)
First posted: 11 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
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	Drug: 1/bag of Jinlida granules, 3 times/day, taken with hot water.General lifestyle intervention+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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Age range from 18 to 65 years old, including both ends;
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.

Key exclusion criteria (36 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1/bag of Jinlida granules, 3 times/day, taken with hot water.Also: General lifestyle interventionAll observation and intervention groups received lifestyle interventions, with only the intervention group of high-risk obese impaired glucose tolerance receiving intervention with Jinlida granules.	Drug	Intervention group of high-risk obese impaired glucose tolerance

Primary outcome

incidence of diabetes
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Fengmei Lian, doctor contact

13651249262

694397644@qq.com

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fengmei Lian, doctor (13651249262, 694397644@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of diabetes (time frame: Both the observation group and the intervention group were followed up for 12 months, once a month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06495814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.