NCT06825182RecruitingPhase 3
Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Feb 2025
- Start date
- 7 Nov 2024
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06825182
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 7 Nov 2024 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have used systemic glucocorticoid therapy within the past 3 months;
Other illness
- Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m\^2;
- History of using blood sugar-lowering medications;
- History of drug abuse or alcohol dependence within the past 5 years;
- History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
- 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.
Lab values
- Estimated glomerular filtration rate (eGFR) less than 30 ml/(min\*1.73 m\^2);
Other
- Patients with poor compliance and irregular diet and exercise;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hostital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.