Status:
NOT_YET_RECRUITING
Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes
Lead Sponsor:
Peking University Third Hospital
Conditions:
T2D
Eligibility:
All Genders
40-65 years
Brief Summary
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%, ...
Eligibility Criteria
Inclusion
- • 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05980754
Start Date
May 20 2024
End Date
December 30 2025
Last Update
March 15 2024
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