Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- T2D
- Sponsor
- Peking University Third Hospital
- Enrollment
- 90
- Primary Endpoint
- biochemical parameters including level of Glucose
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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%, 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.
Investigators
Dongyang Liu
Principal Investigator
Peking University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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),
Outcomes
Primary Outcomes
biochemical parameters including level of Glucose
Time Frame: through study completion, an average of 1 year
level of Glucose
biochemical parameters including level of insulin
Time Frame: through study completion, an average of 1 year
level of insulin
biochemical parameters including level of C-peptide
Time Frame: through study completion, an average of 1 year
level of C-peptide
Secondary Outcomes
- Liver fat content(1 year)
- pancreatic fat content(1 year)