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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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).
• Поведенческое 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).

Первичные конечные точки

• HbA1c [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• FPG [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• 2hPG [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (5)

• HOMA-IR [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• TC [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• TG [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• LDL-C [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• HDL-C [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Minde road No.1 — Jiangxi

Идентификаторы

NCT: NCT07272343 · 2022efyA04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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