Clinical Trial: Overnight Feeding Study in Glycogen Storage Disease Type 1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)

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 Summary:
Sponsor: University of Zurich

Current Primary Outcome: Maximum fasting time over-night (h) [ Time Frame: Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Zurich

Dates:
Date Received: October 8, 2013
Date Started: November 2013
Date Completion:
Last Updated: March 20, 2015
Last Verified: March 2015