The Impact of Semaglutide Compared to Energy Restriction on 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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); Semaglutide; Caloric Restriction
• Intervention / Treatment: Drug: semaglutide; Behavioral: caloric restriction

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jianping Liu; Phone Number: +8679186274551; Email: ndefy14105@ncu.edu.cn

Study Locations

• China
  • Nanchang
    • Jiangxi, Nanchang, China, 330000
      • Recruiting
      • Minde road No.1
      • Contact: Jianping Liu; Phone Number: +8679186274551; Email: ndefy14105@ncu.edu.cn
      • Contact: Email: ndefy14105@ncu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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).
Active Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	glycated hemoglobin	From enrollment to the end of treatment at 12 weeks
FPG	fasting plasma glucose	From enrollment to the end of treatment at 12 weeks
2hPG	2-hour postprandial glucose	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-IR	homeostasis model assessment of insulin resistance	From enrollment to the end of treatment at 12 weeks
TC	total cholesterol	From enrollment to the end of treatment at 12 weeks
TG	triglycerides	From enrollment to the end of treatment at 12 weeks
LDL-C	low-density lipoprotein	From enrollment to the end of treatment at 12 weeks
HDL-C	high-density lipoprotein	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: semaglutide; Type 2 Diabetes Mellitus; Caloric Restriction
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Energy Intake; semaglutide; Caloric Restriction
• Other Study ID Numbers: 2022efyA04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Some of the data involves patient privacy. If there is a need to share the data, please contact the relevant researchers of this project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes