Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin.
A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.
详细描述
Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.
In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
For the second part of the study, i.e. the open-label registry, 4000 subjects are anicipated.
入排标准
- 年龄范围
- 25 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •HbA1c > 7,5%
- •Body Mass Index (BMI) ≥ 27,5 kg/m2
排除标准
- •acute infections
- •severe diseased with hospital stay during the last 3 months
- •chronic diseases
- •chemotherapy or cortisone treatment
- •weight loss of more than 2 kg per week during the last month
- •smoking cessation during the last 3 months or planned
- •weight-influencing medication
- •pregnancy, breast-feeding or lack of contraception
- •high-level physical activity of more than 1h per day
- •incompatibility with components of the PRMR
- •participation in an other study during the last 6 months
- •For the open-label registry, the only inclusion criterium is type 2 diabetes.
结局指标
主要结局
HbA1c
时间窗: 12 weeks
change in hemoglobin A1c
次要结局
- nutrition(12 weeks and 1 year)
- physical activity(12 weeks and 1 year)
- body weight(12 weeks and 1 year)
- cholesterol(12 weeks and 1 year)
- HbA1c(1 year)
- blood pressure(12 weeks and 1 year)
- fasting blood glucose(12 weeks and 1 year)
- quality of life(12 weeks and 1 year)
- antidiabetic medication(12 weeks and 1 year)
研究者
Stephan Martin
Principal investigator
West German Center of Diabetes and Health