Actively Recruiting
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
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-13
1000
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying newly diagnosed patients with type 2 diabetes to observe the current function of islet alpha cells, which play a role in regulating blood sugar levels. The study aims to evaluate changes in glucose, insulin, C-peptide, and glucagon levels before and after treatment with a drug called GLP-1RA. This is a multicenter, prospective study sponsored by Nanjing First Hospital, Nanjing Medical University, designed to better understand how islet alpha cells function and respond to treatment in diabetes patients. Participants include both outpatient and inpatient newly diagnosed type 2 diabetes patients who will have their demographic data and metabolic markers measured. These include fasting and postprandial glucose, insulin, C-peptide, and glucagon levels, or measurements during an Oral Glucose Tolerance Test at multiple time points. Inpatients experiencing hypoglycemia will have additional hormone tests. All participants receive GLP-1RA treatment for three months, after which the same tests are repeated to assess changes in islet alpha cell function. During the study, participants will undergo blood tests for glucose, insulin, C-peptide, glucagon, and other hormones at baseline and after treatment. Inpatients will be monitored closely for hypoglycemia with additional hormone assessments. Researchers will track changes in glucagon levels over 19 months as the primary outcome. Participants will also have routine evaluations of kidney function and HbA1c. The total study duration includes initial testing, three months of treatment, and follow-up testing to evaluate the effects of GLP-1RA on islet alpha cell function.
CONDITIONS
Brief Title
Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m²
- History of using blood sugar-lowering medications
- Estimated glomerular filtration rate (eGFR) less than 30 ml/(min·1.73 m²)
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants newly diagnosed with type 2 diabetes receive treatment with GLP-1RA for three months. During this time, fasting and postprandial glucose, insulin, C-peptide, and glucagon levels are measured, or an Oral Glucose Tolerance Test (OGTT) is performed along with renal function and HbA1c tests.
Baseline visit and retesting visit after 3 months
Trial Site Locations
Total: 1 location
1
Nanjing First Hostital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
J
Jianhua Ma, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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