Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin
研究概览
简要总结
This study evaluates the effect of SGLT-2 inhibitors (dapagliflozin) on the blood glucose excursions by a continuous glucose monitoring system, the incidence of hypoglycemia and hyperglycemia and change in glycated hemoglobin (HbA1c) level in people had bariatric surgery with and without type 2 diabetes.
详细描述
Dapagliflozin is a highly selective sodium-glucose transporter 2 (SGLT2) inhibitor, an approved drug for the treatment of type 2 diabetes. It leads to urinary glucose excretion and a reduction of weight. This results in a reduction of both fasting and postprandial glucose levels. This is reported that the treatment of type 2 diabetes with dapagliflozin carries a low risk of hypoglycaemia and have a beneficial effect on weight and blood pressure.
This study hypothesized that bariatric surgery is effective for weight loss. But some patients experience large changes in the blood glucose after meals that lead to hyper and hypoglycaemia and weight regain. This study propose that the use of SGLT-2 inhibitors, which lower glucose and body weight by promoting its renal excretion, will reduce glucose variability in patients after bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People diagnosed with type 2 diabetes prior to bariatric surgery.
- •People did not have diabetes prior to bariatric surgery.
- •Willing to participate in this study.
排除标准
- •Type 1 diabetes
- •Secondary diabetes
- •History of ketoacidosis
- •History of pancreatitis and pancreatectomy.
- •History of primary renal glycosuria or hereditary glucose-galactose malabsorption.
- •Active diabetes complications, nephropathy (dipstick positive proteinuria, or reduced eGFR (<60 ml/min), proliferative retinopathy.
- •Clinically significant abnormal liver function test.
- •Pregnant ladies, or intending pregnancy or breastfeeding.
- •Patients using insulin therapy or a sulfonylurea.
- •Uncontrolled hypertension.
- •Uncontrolled thyroid disease.
- •Any history of serious hypertension reaction to the dapagliflozin or SGLT-2 inhibitor.
- •History of malignancy within 5-year of screening.
- •Presence of any other medical condition that would in the opinion of the investigator, preclude safe participation in the study.
- •HbA1c >10.5
- •Unable to sign the consent form.
研究组 & 干预措施
(1) People with type 2 diabetes with post-bariatric surgery
干预措施: Dapagliflozin 10 MG (Drug)
(2) people without diabetes with post-bariatric surgery.
干预措施: Dapagliflozin 10 MG (Drug)
结局指标
主要结局
Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin
时间窗: 12 weeks
Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin
次要结局
- Glucose variability, glycemic control (HbA1c)(12 weeks)
- Glycemic control (HbA1c)(12 weeks)
- change in body weight (Kg)(12 weeks)
- change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)(12 weeks)
研究者
Dr. Ebaa Al Ozairi
Chief Medical Officer
Dasman Diabetes Institute