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Overnight Feeding Study in Glycogen Storage Disease Type 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01961076
First Posted: October 11, 2013
Last Update Posted: March 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention
Glycogen Storage Disease Type 1 (GSD 1) Other: overnight nutrition regime

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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) ]

Enrollment: 5
Study Start Date: November 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: uncooked corn starch
Patients receive uncooked corn starch before bed-time
Other: overnight nutrition regime
Patients receive the specified overnight nutrition regimen
Experimental: modified corn starch
Patients receive modified corn starch before bed-time
Other: overnight nutrition regime
Patients receive the specified overnight nutrition regimen
Experimental: other carbohydrate (starch) containing meal
Patients receive a carbohydrate (starch) containing meal before bed-time
Other: overnight nutrition regime
Patients receive the specified overnight nutrition regimen

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961076


Locations
Switzerland
University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Giatgen Spinas, Prof MD University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01961076     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2013-0161
First Submitted: October 8, 2013
First Posted: October 11, 2013
Last Update Posted: March 23, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Metabolic Diseases
Glycogen Storage Disease
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn