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RECRUITING
NCT06825182
PHASE3

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

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2024-11-07

Completion Date

2025-12-31

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

DRUG

Outpatient 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.

DRUG

Inpatient 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