Overnight Feeding Study in Glycogen Storage Disease Type 1

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01961076

Enrollment

Registered

2013-10-11

Start date

2013-11-30

Completion date

2015-03-31

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycogen Storage Disease Type 1 (GSD 1)

Brief 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.

Interventions

OTHERovernight nutrition regime

Patients receive the specified overnight nutrition regimen

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Maximum fasting time over-night (h)	Maximum fasting time will be measured during each dietary intervention for an average period of 3d (minimum) to 6d (maximum)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026