NCT01897363

Brief Summary

This project will study whether infants with Prader-Willi Syndrome experience low blood sugars after short periods of fasting. This study will also evaluate metabolic markers in the blood to determine if infants with Prader-Willi Syndrome process energy differently than other children during fasting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

July 8, 2013

Last Update Submit

September 24, 2014

Conditions

Prader Willi SyndromeHypoglycemia

Keywords

Prader Willi SyndromeHypoglycemiaFasting study

Outcome Measures

Primary Outcomes (1)

  • Presence of hypoglycemia

    We will determine whether fasting occurs within 6 hours of fasting in infants with Prader-Willi Syndrome

    During 6 hours of fasting

Study Arms (1)

Infants with Prader-Willi Syndrome

Infants between ages 2 to 12 months of age with Prader-Willi Syndrome.

Other: Infants with Prader-Willi Syndrome

Interventions

Infants with Prader-Willi SyndromeOTHER

Participants will be admitted to the outpatient clinical research center for IV placement, blood draws from the IV, poking the participants finger to obtain small amounts of blood and monitored 6 hour fast.

Infants with Prader-Willi Syndrome

Eligibility Criteria

Age2 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants with Prader-Willi Syndrome who have not yet started growth hormone therapy

You may qualify if:

  • Diagnosed with Prader-Willi Syndrome
  • Between ages 2-12 months of age
  • Determined to be in nutritional phase 1a by clinical assessment

You may not qualify if:

  • Treatment with growth hormone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Prader-Willi SyndromeHypoglycemia

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Jennifer L Miller, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

US(1)