Overnight Feeding Study in Glycogen Storage Disease Type 1

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01961076
First received: October 8, 2013
Last updated: October 10, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: November 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961076

Contacts
Contact: Michel Hochuli, MD, PhD michel.hochuli@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition Not yet recruiting
Zurich, ZH, Switzerland, 8091
Sub-Investigator: Michel Hochuli, MD         
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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01961076     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2013-0161
Study First Received: October 8, 2013
Last Updated: October 10, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health

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

ClinicalTrials.gov processed this record on October 21, 2014