The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: semaglutide, caloric restriction.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Semaglutide, Caloric Restriction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug semaglutide
The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12). - Behavioral caloric restriction
The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).
Primary outcome measures
- HbA1c [Time frame: From enrollment to the end of treatment at 12 weeks]
- FPG [Time frame: From enrollment to the end of treatment at 12 weeks]
- 2hPG [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (5)
- HOMA-IR [Time frame: From enrollment to the end of treatment at 12 weeks]
- TC [Time frame: From enrollment to the end of treatment at 12 weeks]
- TG [Time frame: From enrollment to the end of treatment at 12 weeks]
- LDL-C [Time frame: From enrollment to the end of treatment at 12 weeks]
- HDL-C [Time frame: From enrollment to the end of treatment at 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Minde road No.1 — Jiangxi
Identifiers
NCT: NCT07272343 · 2022efyA04