Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Glucose Levels at Minute 0 at Week 12.
研究概览
简要总结
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL).
The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
详细描述
A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load.
12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months.
The remaining 12 patients will receive placebo at the same dose.
There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both sexes
- •Age between 30 and 60 years
- •Metabolic Syndrome according to the IDF criteria
- •Waist circumference
- •Man ≥90 cm
- •Woman ≥80 cm
- •And two of the following criteria
- •High density lipoprotein
- •Man ≤40 mg/dL
- •Woman ≤50 mg/dL
- •Fasting glucose ≥100 mg/dL
- •Triglycerides ≥150 mg/dL
- •Blood pressure ≥130/85 mmHg
- •Informed consent signed
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Hypersensibility to SGLT2 inhibitors
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart or thyroid diseased
- •Previous treatment for the metabolic syndrome components
- •Body Mass Index ≥39.9 kg/m2
- •Fasting glucose ≥126 mg/dL
- •Triglycerides ≥500 mg/dL
- •Total cholesterol ≥240 mg/dL
- •Low density lipoprotein (c-LDL) ≥190 mg/dL
- •Blood Pressure ≥140/90 mmHg
研究组 & 干预措施
Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
干预措施: Dapagliflozin (Drug)
Placebo
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Glucose Levels at Minute 0 at Week 12.
时间窗: Week 12
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Systolic Blood Pressure at Week 12.
时间窗: Week 12
The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Insulinogenic Index (Total Insulin Secretion) at Week 12.
时间窗: Week 12
The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Waist Circumference at Week 12.
时间窗: Week 12
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
High Density Lipoprotein (c-HDL) Levels at Week 12.
时间窗: Week 12
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Diastolic Blood Pressure at Week 12.
时间窗: Week 12
The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Triglycerides Levels at Week 12.
时间窗: Week 12
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.
Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
时间窗: Week 12
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Matsuda Index (Total Insulin Sensitivity) at Week 12.
时间窗: Week 12
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity at week 12.
次要结局
- Body Weight at Week 12.(Week 12)
- Total Cholesterol at Week 12(Week 12)
- AUC of Glucose at Week 12.(Week 12)
- AUC of Insulin at Week 12.(Week 12)
- Glucose at Minute 120 at Week 12.(Week 12)
- Glucose at Minute 60 at Week 12.(Week 12)
- Body Mass Index at Week 12(Week 12)
- Fat Mass at Week 12.(Week 12)
- Low Density Lipoproteins (c-LDL) at Week 12(Week 12)
- Alanine Aminotransferase (ALT) at Week 12.(Week 12.)
- Aspartate Aminotransferase (AST) at Week 12.(Week 12)
- Creatinine at Week 12.(Week 12.)
- Uric Acid at Week 12.(Week 12.)
- Glucose at Minute 30 at Week 12.(Week 12)
- Glucose at Minute 90 at Week 12.(Week 12)
研究者
Manuel González Ortiz
Senior Researcher
University of Guadalajara