The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Nanchang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
semaglutide
DrugThe 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
BehavioralThe caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: semaglutide groupExperimental treatment 1 intervention
Group B: caloric restriction groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
HbA1c
glycated hemoglobin
Time frame
From enrollment to the end of treatment at 12 weeks2
FPG
fasting plasma glucose
Time frame
From enrollment to the end of treatment at 12 weeks3
2hPG
2-hour postprandial glucose
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
HOMA-IR
homeostasis model assessment of insulin resistance
Time frame
From enrollment to the end of treatment at 12 weeks2
TC
total cholesterol
Time frame
From enrollment to the end of treatment at 12 weeks3
TG
triglycerides
Time frame
From enrollment to the end of treatment at 12 weeks4
LDL-C
low-density lipoprotein
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov