Changes in metabolism during fasting
Conditions
Interventions
Group 1: In this study up to 30 healthy adults will fast for 7 days according to the Buchinger fasting protocol. The aim of this study is the descriptive characterization of blood ketones, urine keton
Sponsors
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Understanding and willingness to follow the protocol - Signed informed consent
Exclusion criteria
Exclusion criteria: - People with insulin-dependent diabetes mellitus (type 1 or type 2) or type 2 diabetes mellitus with SGLT-2 inhibitors - People with a known eating disorder or underweight (BMI <18.5) - Known acute or severe psychiatric illness (e.g. psychosis, acute depressive episode) - Persons with known migraine - Severe acute or severe chronic illness (e.g. acute infection, advanced hepatic and renal insufficiency, coronary heart disease, known cardiac arrhythmia, known ventricular or duodenal ulcer, uncontrolled hyperthyroidism, malignant diseases, known seizure disorder (epilepsy)) - Persons with a known history of retinal detachment - A history of known urolithiasis or cholelithiasis - Use of anticoagulants, regular use of painkillers, use of cortisone medications, ß-blockers, diuretics - Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives - Skin alteration at the insertion sites of glucose or ketone sensors (e.g. severe psoriasis vulgaris, severe scarring, severe lipodystrophy, severe rash) - Infection with the hepatitis B virus, the hepatitis C virus, the human immunodeficiency virus or other chronic infectious diseases - Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug abuse - Female participants: pregnancy, lactation, absence of a negative urine pregnancy test (except in the case of menopause, sterilization or hysterectomy) - Employees of the clinical trial site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary target is the time course of the mean daily ketone concentration in the blood in relation to the duration of fasting. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Course of the ketone concentration in the blood within one day in relation to the duration of the fast, as well as after breaking the fast - Course of the ketone concentration in the ISF within one day and over several days depending on the duration of the fast, as well as after breaking the fast - Course of the ketone concentration in the urine within one day (morning/evening) and over several days depending on the duration of the fast - Course of the glucose concentration within one day and over several days depending on the duration of the fast, as well as after breaking the fast - Time to onset of ketosis, defined as blood ketone concentration =0.5 mmol/l for more than two hours - Maximum ketone concentration (blood, ISF) and duration to maximum - Time to resolution of ketosis after breaking fast, defined as blood ketone concentration <0.6 mmol/l - Agreement between blood and urine ketone concentration - Concordance between blood and ISF ketone concentration - Change in body weight at the beginning and end of fasting | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed