NCT02667769

Brief Summary

This is a prospective study with a "crossover design", where fasting with a day of complete fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods are compared in a randomized order. Underlying hypothesis is that at the same basal insulin substitution with the fasting of both protocols , no significant differences in the glucose-day or -night profiles revealed. So the same conclusions regarding the "consistency" of basal insulin dosing revealed during the implementation of the part of patients is rated as more pleasant when calories and carbohydrates-free food are allowed.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

January 26, 2016

Last Update Submit

August 15, 2016

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose day- and night profiles

    24 hours

Study Arms (2)

Fasting day without any food

OTHER

Complete fasting: On a fast day under this Protocol no solid food may be eaten unless it is solid, medically prescribed part of a bedtime snack just before falling asleep (which must sometimes be to prevent nocturnal hypoglycaemia with injection of basal insulin before going to sleep) , Otherwise, the patient have ad libitum access to mineral water and unsweetened tea (possibly a fluid intake restriction should be considered for other diseases).

Other: Fasting day

Fasting day with calorie- & carbohydrate-free food

OTHER

During a fasting day for this protocol, patients may calories in unlimited quantity and (with calorie-free dressing) Take carb food like tomatoes, cucumbers, lettuce to be, both during meal periods and in between, if desired.

Other: Fasting day

Interventions

Fasting dayOTHER

A day of fasting started at 18.00 clock with a blood glucose test and is only started when on the same day no significant hypoglycemia (blood glucose \<55 mg / dl) occurred, and when at 18.00 clock the blood sugar in the defined target range (70-180 mg / dl) is. Carried out during the fasting day standardized blood samples for measurement of plasma glucose with an appropriate laboratory method at 18.00, 20:00, 22:00, 12:00, 2:00, 4:00, 6:45, 9:00, 12:00, 14:00 and again at 18.00 clock. Because the determination of plasma glucose in the laboratory will take some time, is always for guidance and also measured with a fast measurement method, in order to treat at high levels of blood sugar with additional insulin correction, and to treat hypoglycaemia low blood sugar or to prevent hypoglycaemia.

Fasting day with calorie- & carbohydrate-free foodFasting day without any food

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Basal insulin substitution with neutrales Protamin Hagedorn (NPH) -insulin (at least twice a day), insulin detemir (twice a day), insulin glargine (once or twice a day) or with insulin pump
  • Diabetes duration \> 2 years
  • Body-mass-index between 19 and 35 kg/m², including
  • written consent

You may not qualify if:

  • No pregnancy in woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabeteszentrum Bad Lauterberg

Bad Lauterberg im Harz, Lower Saxony, 37431, Germany

Location

Related Publications (1)

  • Haase M, Kahle M, Janert M, Meier JJ, Nauck MA. Basal rate tests (24-hour fasts) performed in type-1 diabetic subjects with either absolute fasting or snacks containing negligible carbohydrate amounts result in similar glucose profiles: A randomized controlled prospective trial. Diabetes Obes Metab. 2017 Jun;19(6):783-790. doi: 10.1111/dom.12868. Epub 2017 Mar 20.

    PMID: 28058800DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Michael A. Nauck, Prof.

    Diabeteszentrum Bad Lauterberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Michael A. Nauck

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

DE(1)