NCT06825182 Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes
| NCT ID | NCT06825182 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2024-11-07 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06825182 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06825182 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT06825182 currently recruiting?
Yes, NCT06825182 is actively recruiting participants. Contact the research team at majianhua196503@126.com for enrollment information.
Where is the NCT06825182 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06825182 clinical trial?
NCT06825182 is sponsored by Nanjing First Hospital, Nanjing Medical University. The trial plans to enroll 1,000 participants.
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