The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

NCT ID: NCT07272343

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2026-06-01

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Semaglutide; Caloric Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

semaglutide group

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).

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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).

caloric restriction group

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).

Group Type: ACTIVE_COMPARATOR

caloric restriction

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Minde road No.1

Jiangxi, Nanchang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianping Liu

Role: CONTACT

ndefy14105@ncu.edu.cn

+8679186274551

Facility Contacts

Jianping Liu

Role: primary

ndefy14105@ncu.edu.cn

+8679186274551

Role: backup

ndefy14105@ncu.edu.cn

Other Identifiers

2022efyA04

Identifier Type: -

Identifier Source: org_study_id