Feasibility and impact on quality of life of therapeutic fasting in people with Type 1 Diabetes Mellitus (T1DM)
- Conditions
- E10Type 1 diabetes mellitus
- Registration Number
- DRKS00017504
- Lead Sponsor
- ehrstuhl für Medizintheorie, Integrative und Anthroposophische Medizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
T1DM diagnosis at least one year prior to the first day of fasting
Availability of a system for continuous glucose monitoring or Free Style libre
Age between 18 and 75 years
Duration of diabetes: > 1 year
Creatinine < 1,00 mg/dl
HbA1c: 5,6 - 8,0 mg/dl
Presence of signed declaration of consent for data acquisition, to fill in questionnaires and to take part in the fasting intervention of 9 days
Legal capacity
Acute psychiatric condition with need for treatment
Severe internal condition
Acute febrile illness
Renal insufficiency and other kidney diseases that need treatment or dialysis
pregnancy
lactation
Any addiction
Tumor disease
BMI < 21 (threat for anorexia)
Diabetes insipidus
application for occupational disability in process
Participation in another clinical or observation study within the last 4 weeks
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ketoacidosis, hypoglycaemia, overall wellbeing (WHO 5), diabetes related problem areas (PAID)
- Secondary Outcome Measures
Name Time Method