Assessing Islet Alpha Cell Function in Type 2 Diabetes Patients

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

This study is testing if a new diabetes treatment can help improve the function of certain cells in the pancreas for people who have just been diagnosed with type 2 diabetes.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06825182 on ClinicalTrials.gov

What this trial studies

This study evaluates the function of islet alpha cells in newly diagnosed type 2 diabetes patients by measuring various hormone levels before and after a 3-month treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will undergo tests to assess their glucose, insulin, C-peptide, and glucagon levels during fasting, postprandial periods, and during an Oral Glucose Tolerance Test (OGTT). The goal is to determine if GLP-1RA treatment improves islet alpha cell function in these patients.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed type 2 diabetes patients aged 18 years or older who can adhere to a regular diet and exercise regimen.

Not a fit: Patients with a history of pancreatitis, pancreatic tumors, or those who are allergic to GLP-1RA may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for managing type 2 diabetes by enhancing islet alpha cell function.

How similar studies have performed: Other studies have shown promising results with GLP-1RA in improving glycemic control, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hostital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Jianhua Ma, professor

Conditions: Type 2 Diabetes Mellitus, Islet Alpha Cell Function, Glucagon-Like Peptide-1 Receptor Agonists