Application of Metformin as Adjuvant Therapy in Overweight and Obese Patients With Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Body fat content and anthropometric parameters
研究概览
简要总结
The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. This leads to the development of insulin resistance, even in patients with type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in overweight and obese patients with type 1 diabetes mellitus.
The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose tissue content as measured by electrical bioimpedance, treated at the Poznan University of Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100 patients are treated with insulin alone (control group, group I). Metformin is administered at least 6 months at a mean dose of 1000 mg/day.
The investigators would like to assess the impact of metformin treatment on metabolic control, insulin resistance and anthropometric parameters in overweight and obese patients with type 1 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years <60 years,
- •duration of diabetes >3 years,
- •lack of metabolic control- HbA1C>7,5% (despite participation in 5-day WHO education program)
- •treated with intensive insulin therapy
排除标准
- •metabolically decompensate diabetes with acetonuria,
- •suspected lack of compliance,
- •lack of glucose and ketones self-monitoring,
- •hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
- •recurrent diabetic ketoacidosis (more than two episodes in the past year)
- •another serious medical illness,
- •pregnancy or sexually active woman unwilling to take birth control.
- •renal impairment (estimated on the value calculated glomerular filtration rate using the MDRD formula-estimated glomerular filtration rate, eGFR<45 mL / min
- •liver cell damage Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) greater than twice the upper normal limit),
- •history of drug or alcohol abuse or those who used this drug before
- •changes in the way of antihypertensive and antihyperlipemic treatment.
结局指标
主要结局
Body fat content and anthropometric parameters
时间窗: 6 months
assessed by electrical bioimpedance using a Tanita BC-418 MA device,
次要结局
- Assessment of metabolic control(6 months)
- Insulin requirement(3 , 6 months)
研究者
Agnieszka Zawada
MD
Poznan University of Medical Sciences