Feasibility and impact on quality of life of therapeutic fasting in people with Type 1 Diabetes Mellitus (T1DM)

Feasibility and impact on quality of life of therapeutic fasting in people with Type 1 Diabetes Mellitus (T1DM) - FaMeD1-Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017504

Enrollment

Registered

2019-07-02

Start date

2018-06-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10

Interventions

Group 1: Evaluating the safety, feasibility and quality of life (WHO-5) of a 7 day Buchinger type fasting intervention in people with Type 1 Diabetes Mellitus with regard to diabetes related problem a

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Ketoacidosis, hypoglycaemia, overall wellbeing (WHO 5), diabetes related problem areas (PAID)	—

Secondary

Measure	Time frame
Physiological secondary outcome parameters: Cessation oft he fast HbA1c-values (measured pre, post and after 4 months’ time) Necessary amounts of carbohydrate and insulin units to prevent ketoacidosis Development of urin pH-values as NAE-values over the course of the fast (measured at time points T0, T3, T5, T9) Development of BGA-values over the course of the fast (measured 1x/day) LDL/HDL (Low Density Lipoprotein/High-density lipoprotein) (measured pre, post and after 4 months’ time) Body weight (measured pre, post and after 4 months’ time) Blood pressure (measured pre, post and after 4 months’ time) Heart rate (measured pre, post and after 4 months’ time) Data from DMP (measured pre, post and after 4 months’ time) Psychometric secondary outcome parameters: 1. Anxiety (HADS) 2. Relevance of Disease questionnaire (IIQ) 3. Physical wellbeing questionnaire (FEW 16) ) Kolip & Schmidt (1999) 4. Situational Mindfulness (CPSC – German) Moderators / predictors: Tolerability according to retrieval of adverse events Documented episodes of slight hypoglycaemia < 70 mg/dl and 3,9 mmol respectively and /or typical signs Number of crisis interventions: serum glucose above 250 mg/ dl and ketone values greater than 6.0	—

Measure

Time frame

Physiological secondary outcome parameters: Cessation oft he fast HbA1c-values (measured pre, post and after 4 months’ time) Necessary amounts of carbohydrate and insulin units to prevent ketoacidosis Development of urin pH-values as NAE-values over the course of the fast (measured at time points T0, T3, T5, T9) Development of BGA-values over the course of the fast (measured 1x/day) LDL/HDL (Low Density Lipoprotein/High-density lipoprotein) (measured pre, post and after 4 months’ time) Body weight (measured pre, post and after 4 months’ time) Blood pressure (measured pre, post and after 4 months’ time) Heart rate (measured pre, post and after 4 months’ time) Data from DMP (measured pre, post and after 4 months’ time) Psychometric secondary outcome parameters: 1. Anxiety (HADS) 2. Relevance of Disease questionnaire (IIQ) 3. Physical wellbeing questionnaire (FEW 16) ) Kolip & Schmidt (1999) 4. Situational Mindfulness (CPSC – German) Moderators / predictors: Tolerability according to retrieval of adverse events Documented episodes of slight hypoglycaemia < 70 mg/dl and 3,9 mmol respectively and /or typical signs Number of crisis interventions: serum glucose above 250 mg/ dl and ketone values greater than 6.0

—

Countries

Germany

Contacts

Public ContactBettina Berger

Forschungs- und Lehrzentrum Herdecke (FLZ) am Lehrstuhl für Medizintheorie, Integrative und Anthroposophische Medizin der Universität Witten/Herdecke

dianakoblos@gmail.com02330-62-4763

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026