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

NCT05980754 | Not Yet Recruiting

• 1 other identifier: DCTC-IIR202305
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

T2D

Outcome Measures

Primary Outcomes (3)

• biochemical parameters including level of Glucose

  level of Glucose

  through study completion, an average of 1 year

• biochemical parameters including level of C-peptide

  level of C-peptide

  through study completion, an average of 1 year

• biochemical parameters including level of insulin

  level of insulin

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Liver fat content

  1 year

• pancreatic fat content

  1 year

Study Arms (3)

Healthy group

No intervention

pre diabetic patients

No intervention

T2DM patients

No intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Annual physical examination population conducted by the Physical Examination Center of the Third Hospital of Beijing Medical University

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: August 8, 2023
• Study Start: May 20, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03