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

Sponsor
Second Affiliated Hospital of Nanchang University
Study ID
NCT07272343
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Feb 10, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

HbA1c [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

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