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Overnight Feeding Study in Glycogen Storage Disease Type 1

NCT01961076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-03-23

No results posted yet for this study

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.

Conditions

  • Glycogen Storage Disease Type 1 (GSD 1)

Interventions

OTHER

overnight nutrition regime

Patients receive the specified overnight nutrition regimen

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Giatgen Spinas, Prof MD · University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961076 on ClinicalTrials.gov