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NCT Number: NCT07272343

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

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

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).

Primary outcomes

  1. HbA1c

    Time frame: From enrollment to the end of treatment at 12 weeks

    glycated hemoglobin

  2. FPG

    Time frame: From enrollment to the end of treatment at 12 weeks

    fasting plasma glucose

  3. 2hPG

    Time frame: From enrollment to the end of treatment at 12 weeks

    2-hour postprandial glucose

Secondary outcomes

  1. HOMA-IR

    Time frame: From enrollment to the end of treatment at 12 weeks

    homeostasis model assessment of insulin resistance

  2. TC

    Time frame: From enrollment to the end of treatment at 12 weeks

    total cholesterol

  3. TG

    Time frame: From enrollment to the end of treatment at 12 weeks

    triglycerides

  4. LDL-C

    Time frame: From enrollment to the end of treatment at 12 weeks

    low-density lipoprotein

  5. HDL-C

    Time frame: From enrollment to the end of treatment at 12 weeks

    high-density lipoprotein

Study contacts

Contact information is provided by the study sponsor or research team.

Jianping Liu

CONTACT

[email protected]

+8679186274551

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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