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

Nanjing Medical University

Status and phase

Enrolling

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Inpatient newly diagnosed type 2 diabetes subjects

Drug: Outpatient newly diagnosed type 2 diabetes subjects

Study type

Interventional

Funder types

Other

Identifiers

NCT06825182

KY20240514-11

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.