Semaglutide versus calorie restriction for adults with type 2 diabetes
A Study on the Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes Combined With Metabolic-associated Fatty Liver Disease and Its Molecular Mechanisms
This study will test whether 12 weeks of semaglutide injections or a reduced-calorie diet better improves blood sugar, weight, liver fat, and inflammation in adults newly diagnosed with type 2 diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Jiangxi, Nanchang) |
| Trial ID | NCT07272343 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional study compares 12 weeks of subcutaneous semaglutide injections with a concurrent energy-restricted dietary program in adults recently diagnosed with type 2 diabetes. Eligible participants are 18–75 years old with BMI ≥25 kg/m², HbA1c ≤8.5%, diabetes duration ≤3 months, and no prior antihyperglycemic medications. Key outcomes include glycemic control, weight loss, inflammatory markers, liver fat content, measures of subcutaneous and visceral fat, and exploratory molecular mechanism analyses. The single-center study is conducted at the Second Affiliated Hospital of Nanchang University with scheduled follow-up visits to monitor treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 years old with BMI ≥25 kg/m², newly diagnosed type 2 diabetes (≤3 months), HbA1c ≤8.5%, not currently on antihyperglycemic drugs, and willing to follow the treatment plan and attend follow-up visits.
Not a fit: Patients with BMI <25, longer-standing diabetes, HbA1c >8.5%, prior bariatric surgery, recent weight-loss treatment, or current use of excluded diabetes medications are different from the enrolled population and may not benefit from these findings.
Why it matters
Potential benefit: If successful, the results could show whether starting semaglutide early gives greater short-term improvements in blood sugar, weight, liver fat, and inflammation than calorie restriction alone.
How similar studies have performed: Large trials have shown GLP-1 receptor agonists like semaglutide and calorie restriction each improve glycemic control and weight, but direct short-term head-to-head comparisons in newly diagnosed patients are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jiangxi, Nanchang
- Minde road No.1 — Jiangxi, Nanchang, China (Recruiting)
Study contacts
- Study coordinator: Jianping Liu
- Email: ndefy14105@ncu.edu.cn
- Phone: +8679186274551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.