Late Night Snack and Insulin Glargine

NCT ID: NCT02871180

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31

Brief Summary

Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.

Detailed Description

The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

With late night snack

At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten from Type 1 diabetic patients on an intensified conventional treatment regimen.

Group Type: OTHER

Late night snack

Intervention Type: DIETARY_SUPPLEMENT

The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.

Without late night snack

Not nutrients (No late night snack) were consumed at 10 p.m. from Type 1 diabetic patients on an intensified conventional treatment regimen..

Group Type: OTHER

No late night snack

Intervention Type: OTHER

Patient consumed no nutrients at late night.

Interventions

Late night snack

The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.

Intervention Type: DIETARY_SUPPLEMENT

No late night snack

Patient consumed no nutrients at late night.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 1 diabetes
• Basal insulin substitution with insulin glargine at least 3 month

Exclusion Criteria

• Severe disorders
• Severe and clinical significant gastroparesis
• History of pancreatitis or pancreatic cancer
• Severe Liver disorder (liver enzymes > three times upper normal limit)
• Pregnancy
• Drug- or alcohol abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabeteszentrum Bad Lauterberg im Harz

OTHER

Sponsor Role: lead

Responsible Party

Michael A. Nauck

Prof. Dr. med. Michael A. Nauck

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A. Nauck, Prof.

Role: PRINCIPAL_INVESTIGATOR

St. Josef-Hospital

Locations

Diabeteszentrum Bad Lauterberg

Bad Lauterberg im Harz, Lower Saxony, Germany

Countries

Germany

Other Identifiers

Late night snack & Lantus

Identifier Type: -

Identifier Source: org_study_id