RecruitingPhase 3NCT06825182

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

Survey on the Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes and Interventional Study of GLP-1RA: a Multicenter, Prospective Study


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

1,000 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how the alpha cells of the pancreas — which produce a hormone called glucagon that raises blood sugar — function in people with diabetes, to better understand why blood sugar control is difficult in some patients. **You may be eligible if...** - You have been diagnosed with type 1 or type 2 diabetes - You are an adult (18 or older) - You are willing to have blood drawn and undergo a standardized glucose challenge test - Your diabetes management is relatively stable **You may NOT be eligible if...** - You have severely uncontrolled diabetes with very high HbA1c - You have severe kidney, liver, or pancreatic disease unrelated to diabetes - You are pregnant or breastfeeding - You have had recent major surgery or a serious illness - You have a rare condition affecting glucagon response Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOutpatient newly diagnosed type 2 diabetes subjects

Outpatient newly diagnosed type 2 diabetes subjects, who have signed the informed consent form, meet the inclusion and exclusion criteria, and have their demographic data collected, including height, weight, systolic and diastolic blood pressure, and calculation of the body mass index (BMI) = weight/height\^2 (kg/m\^2). Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is performed, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested, with eGFR calculated. Type 2 diabetes patients are treated with GLP-1RA for three months, and then the aforementioned indicators are retested to complete the study.

DRUGInpatient newly diagnosed type 2 diabetes subjects

Demographic data are collected. Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is conducted, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested. During hospitalization, if hypoglycemic symptoms occur or peripheral blood glucose or continuous glucose monitoring is ≤3.9 mmol/L, immediate venous blood is drawn for glucose, GCG, adrenocorticotropic hormone (ACTH), cortisol (Cor), growth hormone (GH), and Cp testing. Patients are treated with GLP-1RA for three months, then the aforementioned indicators are retested to complete the study and hypoglycemia (including hypoglycemic clamp and hypoglycemia tests) is assessed for glucose and GCG, with additional tests for ACTH, Cor, GH, and Cp if conditions permit, to complete the study.


Locations(1)

Nanjing First Hostital

Nanjing, Jiangsu, China

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NCT06825182


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