NCT07272343 The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes
| NCT ID | NCT07272343 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital of Nanchang University |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-02-10 |
| Primary Completion | 2026-06-30 |
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 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-02-10 with a primary completion date of 2026-06-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years; 2. BMI≥25 kg/m²; 3. Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)"; 4. HbA1c≤8.5%; 5. Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs; 6. 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: 1. BMI \< 25 kg/m²; 2. Age \< 18 years, or \> 75 years; 3. History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy; 4. 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; 5. 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; 6. Pregnant or breastfeeding women, or those planning to conceive during the study period; 7. 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; 8. Personal or family history of medullary thyroid carcinoma; 9. Patients with severe mental disorders or communication barriers that prevent accurate understanding of the study content and compliance with the trial procedures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07272343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes Mellitus (T2DM). 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 NCT07272343 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07272343 currently recruiting?
Yes, NCT07272343 is actively recruiting participants. Contact the research team at ndefy14105@ncu.edu.cn for enrollment information.
Where is the NCT07272343 trial being conducted?
This trial is being conducted at Jiangxi, China.
Who is sponsoring the NCT07272343 clinical trial?
NCT07272343 is sponsored by Second Affiliated Hospital of Nanchang University. The trial plans to enroll 100 participants.
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