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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

November 7, 2024

Primary Completion Date

August 1, 2025

Study Completion Date

December 31, 2025

Conditions
Type 2 Diabetes Mellitus
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.

Trial Locations (1)

210000

RECRUITING

Nanjing First Hostital, Nanjing

All Listed Sponsors
lead

Nanjing First Hospital, Nanjing Medical University

OTHER