MedPath

Overnight Feeding Study in Glycogen Storage Disease Type 1

Not Applicable
Completed
Conditions
Glycogen Storage Disease Type 1 (GSD 1)
Interventions
Other: overnight nutrition regime
Registration Number
NCT01961076
Lead Sponsor
University of Zurich
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
uncooked corn starchovernight nutrition regimePatients receive uncooked corn starch before bed-time
modified corn starchovernight nutrition regimePatients receive modified corn starch before bed-time
other carbohydrate (starch) containing mealovernight nutrition regimePatients receive a carbohydrate (starch) containing meal before bed-time
Primary Outcome Measures
NameTimeMethod
Maximum fasting time over-night (h)Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition

🇨🇭

Zurich, ZH, Switzerland

© Copyright 2025. All Rights Reserved by MedPath