Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes

Comparison of Two Protocols on the Implementation of a Fasting Day to Check the Basal Insulin Replacement in Type 1 Diabetes: Complete Fasting Compared to the Permission for Carbohydrate- and Calorie-free Food

Sponsors

Lead Sponsor: Diabeteszentrum Bad Lauterberg im Harz

Source Diabeteszentrum Bad Lauterberg im Harz
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.

Overall Status Unknown status
Start Date August 2014
Primary Completion Date June 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Plasma glucose day- and night profiles 24 hours
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: Fasting day

Description: 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.

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- No pregnancy in woman

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michael A. Nauck, Prof. Principal Investigator Diabeteszentrum Bad Lauterberg
Location
Facility: Diabeteszentrum Bad Lauterberg
Location Countries

Germany

Verification Date

August 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Diabeteszentrum Bad Lauterberg im Harz

Investigator Full Name: Michael A. Nauck

Investigator Title: Prof. Dr. med. Michael A. Nauck

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Fasting day without any food

Type: Other

Description: 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).

Label: Fasting day with calorie- & carbohydrate-free food

Type: Other

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov