ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
研究概览
简要总结
Weight control is an essential part of treatment for type 2 diabetes (T2D) patients. Weight loss is associated with decreased haemoglobin A1c (A1c) levels. In particular, visceral fat is accompanied by more alterations in glucose and lipid metabolism. Quantification of visceral fat with bioimpedance (BIA) is closely related to measurement with computed axial tomography. Different available oral antidiabetics cause weight loss and total body fat (biguanides, DPP-4 inhibitors and SGLT-2 inhibitors), but it has only been shown that SLGT2 inhibitors decrease visceral fat. Therefore, the aim of this study is to determine whether there is a difference in the amount of visceral fat measured with BIA in T2D patients between three oral antidiabetic regimens after twelve weeks of treatment, to compare the effect on visceral fat between metformin, DPP4 inhibitors and SGLT2 inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients +18 years
- •Patients with visceral fat quantification by BIA at baseline and week twelve
- •Patients with body mass index >25
- •Patients can swallow tablets
排除标准
- •Patients treated with other oral antidiabetic agents or insulin
- •Glomerular filtration rate less than 30 mL/min
- •Transaminemia greater than 2 times the upper reference value
- •Pregnancy
- •Malnutrition
研究组 & 干预措施
Metformin
Metformin 1.7-2.5mg per day during twelve weeks
干预措施: Biguanide, DPP4 inhibitors, SGLT2 inhibitors (Drug)
Metformina + IDDP-4
Metformin 1.7-2.5mg per day plus Linagliptin 5mg per day or Sitagliptin 50-100mg per day
干预措施: Biguanide, DPP4 inhibitors, SGLT2 inhibitors (Drug)
Metformina + ISGLT-2
Metformin 1.7-2.5mg per day plus Empaglifozin 10-25mg per day or Dapaglifozin 10mg per day
干预措施: Biguanide, DPP4 inhibitors, SGLT2 inhibitors (Drug)
结局指标
主要结局
Change from baseline in visceral fat measured by bioimpedance in kg at weet twelve
时间窗: Baseline and week twelve
Bioimpedance is a confident method to measured visceral fat
次要结局
未报告次要终点
研究者
Alonso Alberto Castro Arguelles
Metabolic Research Unit
Metabolic Research Unit