Overnight Feeding Study in Glycogen Storage Disease Type 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

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In this clinical cross-over study, we will compare the efficacy of different oral nutrition regimens for night-time glucose control in adult GSD 1 patients. Three different over-night nutrition regimens (=interventions) will be compared in each patient sequentially, (1) uncooked corn starch (UCSS, "Maizena"), (2) modified corn-starch, (3) other carbohydrate (starch) containing meal. During each intervention, glucose profiles will be continuously monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the technical quality of glucose sensor readings. Between the interventions, the patients follow their normal prescribed diet.

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Detailed Description

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Conditions

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Glycogen Storage Disease Type 1 (GSD 1)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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uncooked corn starch

Patients receive uncooked corn starch before bed-time

Group Type EXPERIMENTAL

overnight nutrition regime

Intervention Type OTHER

Patients receive the specified overnight nutrition regimen

modified corn starch

Patients receive modified corn starch before bed-time

Group Type EXPERIMENTAL

overnight nutrition regime

Intervention Type OTHER

Patients receive the specified overnight nutrition regimen

other carbohydrate (starch) containing meal

Patients receive a carbohydrate (starch) containing meal before bed-time

Group Type EXPERIMENTAL

overnight nutrition regime

Intervention Type OTHER

Patients receive the specified overnight nutrition regimen

Interventions

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overnight nutrition regime

Patients receive the specified overnight nutrition regimen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Glycogen storage disease type 1 (type 1a and 1b)
* Stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements.

Exclusion Criteria

* Unstable night-time glucose control during the last 8 weeks with frequent (\> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks.
* Pregnancy or breast feeding
* Drug or alcohol abuse
* Acute gastrointestinal problems (e.g. acute gastroenteritis)
* Known malignancy (e.g. hepatocellular carcinoma)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No