This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research Article
Seven-day Fasting as a multimodal complex intervention for Adults with Type 1 Diabetes – Feasibility, Benefit and Safety in a Controlled Pilot Study
Bettina Berger
University Witten/Herdecke
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- This study is a case report.
- The author has confirmed that consent for publication of clinical details and/or clinical images was obtained from the patient/parent/guardian/relative of the patient or waiver of such consent is described in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
View the published version here.
Aims/Hypothesis: Intermittent as well as prolonged fasting are receiving considerable attention and appear favorable in conditions like the metabolic syndrome, type 2 diabetes, rheumatic diseases and others. Fasting for people with type 1 diabetes is generally considered too risky. However, the ability and possibility to change from carbohydrate to ketone-based fuel supply may also be relevant for people with type 1 diabetes. The aim of this patient-led research was to investigate the feasibility, benefit and safety of a seven-day multimodal fasting intervention in people with type 1 diabetes.
Methods: A non-randomized controlled pilot study, with 20 participants with and 10 without type 1 diabetes with data acquisition toking place prior, post and four months after the intervention and daily during intervention.
Results: 29 of 30 participants finished the intervention. Mean ß-hydroxybutyrate as representative ketone body increased to 2.8 ± 1.9 mmol/L on day 7 while average glucose remained between 4.9 ± 1.5 to 7.5 ± 2.3 mmol/L89 [± 27 and 136 ± 40 mg/dL]. Fasting-related side effects were all temporary, and slightly more prevalent in those with type 1 diabetes. Mean daily insulin dose was adjusted from 24.4 (3-50) IU on the day before fasting to 7.6 (0-26.7) IU on day 7. Quality of life (WHO-5) normalized from 54.0 ± 4.4 to 68.8 ± 15.0 (p = 0.01) after fasting. The was a decrease from before until the follow -up four month late of weight from 77.6 ± 20.4 kg to 76.6 ± 20.9 kg (p = 0.023) and for the BMI from (27.68 ± 7.04) to (26.74 ± 7.15) kg/m2 (p = 0.008). Diastolic blood pressure increased from 69.75 ± 11.41 mmHg to 75.74 ± 8.42 mmHg (p = 0.028) and stayed in a healthy range on average.
Conclusions/Interpretation: This study demonstrates the feasibility, benefits and safety aspects of a 7-day fast in adults with type 1 diabetes.
Keywords
type 1 diabetes, prolonged fasting, ketosis, feasibility, patient - led research, multimodal intervention, prevention
This is a list of supplementary files associated with this preprint. Click to download.
- FaMeD1Supp2TimeTable.docx
FaMeD1_Figure 2 Time Table
- FaMeD1Figure3KetonesbodiesandGlucosewithT1DM.doc
FaMeD1_Figure3_ Ketone bodies and Glucose
- FaMeD1Supp4Ketonebodydevelopment.docx
FaMeD1-Figure 4 _ Ketone body development under fasting
- FaMeD1Supp1Figure1.docx
FaMeD1- Figure 1 Flow Chart
- GraphicalAbstract34.pdf
Marina Barzen
commented on 01 September, 2020
I fasted 2 weeks ago for 5 days and from day 3 on without insulin. I am a Typ 1 diabetic for 24 years now. It is a great feeling to live without insulin. Even if it's only for a couple of days...
View 1 reply
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Published
On 22 Jan, 2021
No community comments so far
Version 1
Posted 19 Aug, 2020
Community comments: 2
Metrics
Comments: 2
PDF Downloads: ...
HTML Views: ...
Subject Areas
Endocrinology & Metabolism
Learn more about our company.
This is a preprint. It has not completed peer review.
Research Article
Seven-day Fasting as a multimodal complex intervention for Adults with Type 1 Diabetes – Feasibility, Benefit and Safety in a Controlled Pilot Study
Bettina Berger
University Witten/Herdecke
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Published
On 22 Jan, 2021
No community comments so far
Version 1
Posted 19 Aug, 2020
Community comments: 2
Metrics
Comments: 2
PDF Downloads: ...
HTML Views: ...
Subject Areas
Endocrinology & Metabolism
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- This study is a case report.
- The author has confirmed that consent for publication of clinical details and/or clinical images was obtained from the patient/parent/guardian/relative of the patient or waiver of such consent is described in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
View the published version here.
Aims/Hypothesis: Intermittent as well as prolonged fasting are receiving considerable attention and appear favorable in conditions like the metabolic syndrome, type 2 diabetes, rheumatic diseases and others. Fasting for people with type 1 diabetes is generally considered too risky. However, the ability and possibility to change from carbohydrate to ketone-based fuel supply may also be relevant for people with type 1 diabetes. The aim of this patient-led research was to investigate the feasibility, benefit and safety of a seven-day multimodal fasting intervention in people with type 1 diabetes.
Methods: A non-randomized controlled pilot study, with 20 participants with and 10 without type 1 diabetes with data acquisition toking place prior, post and four months after the intervention and daily during intervention.
Results: 29 of 30 participants finished the intervention. Mean ß-hydroxybutyrate as representative ketone body increased to 2.8 ± 1.9 mmol/L on day 7 while average glucose remained between 4.9 ± 1.5 to 7.5 ± 2.3 mmol/L89 [± 27 and 136 ± 40 mg/dL]. Fasting-related side effects were all temporary, and slightly more prevalent in those with type 1 diabetes. Mean daily insulin dose was adjusted from 24.4 (3-50) IU on the day before fasting to 7.6 (0-26.7) IU on day 7. Quality of life (WHO-5) normalized from 54.0 ± 4.4 to 68.8 ± 15.0 (p = 0.01) after fasting. The was a decrease from before until the follow -up four month late of weight from 77.6 ± 20.4 kg to 76.6 ± 20.9 kg (p = 0.023) and for the BMI from (27.68 ± 7.04) to (26.74 ± 7.15) kg/m2 (p = 0.008). Diastolic blood pressure increased from 69.75 ± 11.41 mmHg to 75.74 ± 8.42 mmHg (p = 0.028) and stayed in a healthy range on average.
Conclusions/Interpretation: This study demonstrates the feasibility, benefits and safety aspects of a 7-day fast in adults with type 1 diabetes.
Marina Barzen
commented on 01 September, 2020
I fasted 2 weeks ago for 5 days and from day 3 on without insulin. I am a Typ 1 diabetic for 24 years now. It is a great feeling to live without insulin. Even if it's only for a couple of days...
View 1 reply
Bettina
replied on 02 September, 2020
Dear Marina, thanks for your comment! We usually do not recommend to stop insulin substitution completely, because this might cause the risk of even higher need of insulin later. Only in LADA diabetes it might be possible without risk, because self-regulation still is better in LADA diabetes. But we do not have enough data to show this and urgently need more research. Bettina
Bettina
replied on 02 September, 2020
Dear Marina, thanks for your comment! We usually do not recommend to stop insulin substitution completely, because this might cause the risk of even higher need of insulin later. Only in LADA diabetes it might be possible without risk, because self-regulation still is better in LADA diabetes. But we do not have enough data to show this and urgently need more research. Bettina