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Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes

RecruitingPhase 3Ages 18 Years - anyAllNanjing First Hospital, Nanjing Medical University
NCT06825182 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Willing to participate voluntarily and able to sign the Informed Consent Form before the trial; * Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria; * Subjects who are capable and willing to maintain a regular diet and exercise regimen. Exclusion Criteria: * Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m\^2; * History of using blood sugar-lowering medications; * Estimated glomerular filtration rate (eGFR) less than 30 ml/(min\*1.73 m\^2); * History of drug abuse or alcohol dependence within the past 5 years; * Patients with poor compliance and irregular diet and exercise; * History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher; * Patients who have used systemic glucocorticoid therapy within the past 3 months; * Presence of infection or stress within the past four weeks; * Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.
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What it tests

  • Outpatient newly diagnosed type 2 diabetes subjects
  • Inpatient newly diagnosed type 2 diabetes subjects
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Where

1 site
Nanjing First Hostital
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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