Applying a digital, personalized, low-glycemic nutritional program in patients with a non-insulin treated type 2 diabetes mellitusA one-armed pilot study over a period of 12 weeks - Metabolic I

Perfood GmbH0 个研究点目标入组 75 人开始时间: 2021年8月4日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Type 2 diabetes mellitus E11, - without insulin treatment based on at least two of the following tests:
•o HbA1c = 6.5% (48 mmol / mol)
•o Fasting plasma glucose = 126 mg / dl (7 mmol / l)
•o OGTT-2 hours = 200 mg / dl (11.1 mmol / l)
•o Occasional plasma glucose = 200 mg / dL (11.1 mmol / L) with typical diabetes-related symptoms
•- HbA1c = 6.5% (48 mmol / mol) at the last clinical routine check (within the last 12 months);
•- Treatment with one of the following options (unchanged since at least 3 months)
•1. Lifestyle modification only
•2. metformin
•3. SGLT-2 inhibition
•4. GLP-1 analogs
•5. DPP4 inhibition
•6. any combination of drugs from 2 to 5.
•- Body Mass Index (BMI)> 27 and = 40 kg / m2;
•- Written declaration of consent;
•- Good understanding of written and spoken German;
•- Use of an Android smartphone (version 5.1 or higher) or iOS smartphones (version 13.0 or higher);
•- Intellectual capacity and willingness to change Lifestyle according to the dietary recommendations

•- Use of a Perfood GmbH product with a glucose monitoring test phase within the past 24 months;
•- Antibiotic treatment (systemic, longer than 1 day) within the last 3 months;
•- Pregnancy, breastfeeding or active desire to have children (acc. patient information);
•- Eating disorder, e.g. binge eating, bulimia, anorexia nervosa;
•- Alcohol or drug abuse;
•- Current and planned participation in another clinical study;
•- Current insulin treatment;
•- HbA1c = 8.5% (70 mmol / mol);
•- Weight change of = 5% of the initial body weight within the last 3 months;
•- last eGFR <30 ml / min / 1.73 m2;
•- Known tumor disease (exception: remission after treatment for at least 2 years);
•- Myocardial infarction within the last 6 months;
•- Severe heart failure defined as equivalent to class 3 the New York Heart Association (NYHA);
•- Current treatment with anti-obesity drugs

发起方

Perfood GmbH