Overnight Feeding Study in Glycogen Storage Disease Type 1

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Brief Title

Overnight Feeding Study in Glycogen Storage Disease Type 1

Official Title

New Approaches for Over-night Feeding in 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.
    



Study Type

Interventional


Primary Outcome

Maximum fasting time over-night (h)


Condition

Glycogen Storage Disease Type 1 (GSD 1)

Intervention

overnight nutrition regime

Study Arms / Comparison Groups

 uncooked corn starch
Description:  Patients receive uncooked corn starch before bed-time

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

5

Start Date

November 2013

Completion Date

March 2015

Primary Completion Date

March 2015

Eligibility 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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Giatgen Spinas, Prof MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT01961076

Organization ID

KEK-ZH-Nr. 2013-0161


Responsible Party

Sponsor

Study Sponsor

University of Zurich


Study Sponsor

Giatgen Spinas, Prof MD, Principal Investigator, University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition


Verification Date

March 2015