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NCT Number: NCT01961076

Overnight Feeding Study in Glycogen Storage Disease Type 1

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.

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Key information

Conditions

Glycogen Storage Disease Type 1 (GSD 1) Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glycogen Storage Disease Glycogen Storage Disease Type I Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

overnight nutrition regime

Other

Patients receive the specified overnight nutrition regimen

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2013
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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