Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes

Sponsor

Peking University Third Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05980754

Collaborator

(none)

Enrollment

28.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Explore the high related factors of impaired glucose tolerance through descriptive statistics and analysis of variance.

Condition or Disease	Intervention/Treatment	Phase
T2D

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

90 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Healthy group No intervention
pre diabetic patients No intervention
T2DM patients No intervention

Outcome Measures

Primary Outcome Measures

biochemical parameters including level of Glucose [through study completion, an average of 1 year]
level of Glucose
biochemical parameters including level of C-peptide [through study completion, an average of 1 year]
level of C-peptide
biochemical parameters including level of insulin [through study completion, an average of 1 year]
level of insulin

Secondary Outcome Measures

Liver fat content [1 year]
magnetic resonance imaging proton density fat fraction (MRI-PDFF)
pancreatic fat content [1 year]
magnetic resonance imaging proton density fat fraction (MRI-PDFF)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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),
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,

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dongyang Liu, Principal Investigator, Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT05980754

Other Study ID Numbers:

DCTC-IIR202305

First Posted:

Aug 8, 2023

Last Update Posted:

Aug 8, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 8, 2023