T2DNCT05980754
Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes
An observational study of T2D, run by Peking University Third Hospital.
Trial summary
Explore the high related factors of impaired glucose tolerance through descriptive statistics and analysis of variance. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- T2D
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 30 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Annual physical examination population conducted by the Physical Examination Center of the Third Hospital of Beijing Medical University
Who may be able to join
- The diagnostic criteria of the American diabetes Association (ADA) were used to determine the type of subjects: Group Healthy individuals: Glycated hemoglobin (HbA1c) ≤ 5.6%; Group Pre T2DM patients: 5.7% ≤ HbA1c ≤ 6.4%; Group T2DM patients: HbA1c ≥ 6.5% (for T2DM patients: this study needs to include first-time or previously diagnosed patients who have not used hypoglycemic drugs within 4 years and HBA1C ≤ 9.5%)Clinical diagnosis of Alzheimer's Disease.
- Male weight ≥ 50kg, female weight ≥ 45kg, 18.5 < BMI < 24kg/m2
- Age range from 40 years old (inclusive) to 65 years old (inclusive), with no less than one-third of either gender
- Subjects voluntarily sign informed consent forms, can maintain good communication with researchers, and comply with the requirements of clinical trials
Who cannot join
- In the past month and currently taking glucocorticoids, steroids, thiazide diuretics, or atypical antipsychotic drugs
- Some diseases that affect glucose tolerance: type 1 diabetes (T1DM), pancreatic exocrine disease, polycystic ovary syndrome and other endocrine diseases, autoimmune diseases, infection and trauma and other irritability factors
- Diseases that may affect eating: mental illness, post gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease.
- Healthy subjects with a history of gestational diabetes or subjects with direct family members with a family history of diabetes
- Pregnant or lactating women
- Participate in any other clinical trials within 3 months prior to the trial
Show all 21Show fewer
- Blood donation or loss of ≥ 400mL within 8 weeks before the first cycle of the experiment
- Clinically significant history of ECG abnormalities or family history of long QT syndrome (grandparents, parents, siblings) Suffering from any condition that significantly affects glucose absorption, distribution, metabolism, and excretion within 2 weeks prior to the experiment, or any condition that may pose a hazard to the subject, the detailed conditions are as follows:
- History of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding
- A significant history of gastrointestinal surgery (such as gastrectomy, gastroenterostomy, or intestinal resection),
- history of pancreatic injury or pancreatitis or clinical evidence, or researchers' judgment of abnormal lipase and amylase,
- abnormal liver function tests (such as ALT, AST, serum bilirubin), which are clinically significant, indicate liver disease, cirrhosis, or liver injury. (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], glutamine transpeptidase [GGT], total bilirubin) greater than three times their respective upper limit of normal (ULN).
- There is a history or evidence of renal dysfunction, manifested as clinically significant creatinine or urinary composition abnormalities (such as tubular type), or eGFR<60 ml/min/1.73m2
- Urinary tract obstruction or difficulty in emptying urine during screening period
- Individuals with any form of medical/implant intolerance, including pacemakers, metal plates, or magnetic resonance imaging (MRI)
- Individuals who have tested positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or syphilis (results within six months are exempt from testing)
- Smokers who smoke more than 10 cigarettes or an equivalent amount of tobacco per day cannot stop smoking during the trial period
- There is a history of drug or alcohol abuse within the 12 months prior to the trial, or evidence of abuse is found during laboratory testing during screening evaluation
- During screening, lying blood pressure (after resting for 5 minutes) exceeds the range of 90-140mm Hg (including 90140) in systolic blood pressure, 50-90 mmHg (including 50, 90) in diastolic blood pressure, or heart rate (HR) exceeds the range of 50 bpm to 100 bpm (including 50100) in heart rate (HR)
- Tumor patients
- Participants are not suitable for the experiment
About this study
Explore the high related factors of impaired glucose tolerance through descriptive statistics and analysis of variance.
Read the detailed description
This study is a cross-sectional study planned to include healthy individuals with a BMI within the normal range (18.5<BMI<24 kg/m2) (HbA1c ≤ 5.6%, n=18), pre diabetic patients (5.7% ≤ HbA1c ≤ 6.4%, n=36), and T2DM patients (HbA1c ≥ 6.5%, n=36) among individuals who meet the inclusion criteria and undergo annual physical examinations at the Physical Examination Center of the Third Hospital of Beijing Medical University. Collect the examination values related to demography and glucose metabolism balance of physical examination items, and carry out magnetic resonance imaging (MRI) imaging examination and oral glucose tolerance test (OGTT) results. Explore the high related factors of impaired glucose tolerance through descriptive statistics and analysis of variance.
- Conditions
- T2D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | No intervention | |
| pre diabetic patients | No intervention | |
| T2DM patients | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical parameters including level of Glucose
level of Glucose
Measured: through study completion, an average of 1 year
biochemical parameters including level of C-peptide
level of C-peptide
Measured: through study completion, an average of 1 year
biochemical parameters including level of insulin
level of insulin
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Liver fat content
magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured: 1 year
pancreatic fat content
magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start20 May 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyang Liu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980754
- Sponsor's protocol ID
- DCTC-IIR202305
- Status last verified
- Mar 2024
- First submitted
- 17 Apr 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes
- ClinicalTrials.gov ID
- NCT05980754
- Acronym / sponsor ID
- DCTC-IIR202305
- Conditions
- T2D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Aug 2023 (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.
Explore the high related factors of impaired glucose tolerance through descriptive statistics and analysis of variance.
Detailed description
This study is a cross-sectional study planned to include healthy individuals with a BMI within the normal range (18.5<BMI<24 kg/m2) (HbA1c ≤ 5.6%, n=18), pre diabetic patients (5.7% ≤ HbA1c ≤ 6.4%, n=36), and T2DM patients (HbA1c ≥ 6.5%, n=36) among individuals who meet the inclusion criteria and undergo annual physical examinations at the Physical Examination Center of the Third Hospital of Beijing Medical University. Collect the examination values related to demography and glucose metabolism balance of physical examination items, and carry out magnetic resonance imaging (MRI) imaging examination and oral glucose tolerance test (OGTT) results. Explore the high related factors of impaired glucose tolerance through descriptive statistics and analysis of variance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | –No intervention |
| pre diabetic patients | – | –No intervention |
| T2DM patients | – | –No intervention |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Annual physical examination population conducted by the Physical Examination Center of the Third Hospital of Beijing Medical University
Key inclusion criteria (4 listed)
- The diagnostic criteria of the American diabetes Association (ADA) were used to determine the type of subjects: Group Healthy individuals: Glycated hemoglobin (HbA1c) ≤ 5.6%; Group Pre T2DM patients: 5.7% ≤ HbA1c ≤ 6.4%; Group T2DM patients: HbA1c ≥ 6.5% (for T2DM patients: this study needs to include first-time or previously diagnosed patients who have not used hypoglycemic drugs within 4 years and HBA1C ≤ 9.5%)Clinical diagnosis of Alzheimer's Disease.
- Male weight ≥ 50kg, female weight ≥ 45kg, 18.5 < BMI < 24kg/m2
- Age range from 40 years old (inclusive) to 65 years old (inclusive), with no less than one-third of either gender
- Subjects voluntarily sign informed consent forms, can maintain good communication with researchers, and comply with the requirements of clinical trials
Key exclusion criteria (21 listed)
- In the past month and currently taking glucocorticoids, steroids, thiazide diuretics, or atypical antipsychotic drugs
- Some diseases that affect glucose tolerance: type 1 diabetes (T1DM), pancreatic exocrine disease, polycystic ovary syndrome and other endocrine diseases, autoimmune diseases, infection and trauma and other irritability factors
- Diseases that may affect eating: mental illness, post gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease.
- Healthy subjects with a history of gestational diabetes or subjects with direct family members with a family history of diabetes
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biochemical parameters including level of Glucose
Time frame: through study completion, an average of 1 year
level of Glucose
biochemical parameters including level of C-peptide
Time frame: through study completion, an average of 1 year
level of C-peptide
biochemical parameters including level of insulin
Time frame: through study completion, an average of 1 year
level of insulin
2 secondary outcomes
Liver fat content
Time frame: 1 year
pancreatic fat content
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of T2D, run by Peking University Third Hospital.
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 4 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 15 Mar 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical parameters including level of Glucose (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2024.