The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes
Recruiting · NCT07272343 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital of Nanchang University
View the official record on ClinicalTrials.gov →Interventions studied
caloric restrictionsemaglutide
What this trial is about
To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-75 years;
- BMI≥25 kg/m²;
- Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)";
- HbA1c≤8.5%;
- Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;
- Willing to participate in this study, and after full informed consent, agrees to strictly follow the treatment plan and promises to attend follow-up visits on time, and signs the informed consent form.
Exclusion criteria
- BMI \< 25 kg/m²;
- Age \< 18 years, or \> 75 years;
- History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy;
- History of bariatric surgery or planned bariatric surgery, or currently attempting weight loss within the past 3 months, or use of weight-loss medications within the past 3 months;
- Use of GLP-1 receptor agonists, sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, or other related drugs within the past 3 months;
- Pregnant or breastfeeding women, or those planning to conceive during the study period;
- Patients with severe diseases of important organ systems, such as severe cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, renal insufficiency, hematologic diseases, neurological diseases, or malignancies;
- Personal or family history of medullary thyroid carcinoma;
- Patients with severe mental disorders or communication barriers that prevent accurate understanding of the study content and compliance with the trial procedures.
Where it is running
1 location listed.
- Minde road No.1 - Jiangxi, Nanchang, China