Overnight Feeding Study in Glycogen Storage Disease Type 1

Overview

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.

Full Title of Study: “New Approaches for Over-night Feeding in Glycogen Storage Disease Type 1 (GSD 1)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Interventions

  • Other: overnight nutrition regime
    • Patients receive the specified overnight nutrition regimen

Arms, Groups and Cohorts

  • Experimental: uncooked corn starch
    • Patients receive uncooked corn starch before bed-time
  • Experimental: modified corn starch
    • Patients receive modified corn starch before bed-time
  • Experimental: other carbohydrate (starch) containing meal
    • Patients receive a carbohydrate (starch) containing meal before bed-time

Clinical Trial Outcome Measures

Primary 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)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Giatgen Spinas, Prof MD, Principal Investigator, University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition

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