Prader Willi SyndromeNCT01897363
Hypoglycemia in Prader-Willi Syndrome
An observational study of Prader Willi Syndrome and Hypoglycemia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Prader Willi Syndrome, Hypoglycemia
- What is being tested?
- Infants with Prader-Willi Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants with Prader-Willi Syndrome who have not yet started growth hormone therapy
Who may be able to join
- Diagnosed with Prader-Willi Syndrome
- Between ages 2-12 months of age
- Determined to be in nutritional phase 1a by clinical assessment
Who cannot join
- Treatment with growth hormone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoglycemia in Prader-Willi Syndrome: A Prospective Study
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.
Read the detailed description
This study will include outpatient admission to the 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. A fast is when a person goes without food for a certain period of time. The participant will not be fasted longer than 6 hours.
The participant will arrive to the outpatient clinical research center at approximately 7am. A parent will be expected to stay with the participant at all times. The participant's finger will be poked for blood (requires approximately one drop of blood) soon after arrival to make sure his blood sugar is not already low. If the participant's blood sugar is low on arrival to the Clinical Research Center, additional blood will be drawn through his vein (a little more than half a teaspoon) and he will not have to complete the rest of the study. If his blood glucose is above 60 mg/dl, the participant will be given an opportunity to eat prior to starting the fast. A small tube will be placed in the participant's vein at the beginning of the fast to make additional blood draws easier. 1/10th a teaspoon of blood will be sent for cortisol testing when the IV is placed. Cortisol is a hormone that is important for control of blood sugar. In addition, the participant's finger will be pricked every hour for blood to monitor his blood sugar by bedside meter. Each finger prick will require approximately one to two drops of blood. A test to look at fat breakdown (ketones) will sometimes be checked using the same blood obtained when pricking the finger to check blood sugar. If a blood sugar of less than 70 mg/dl is found, blood sugars will be checked by finger prick every 30 minutes instead of every hour. If finger prick blood glucose is less than 65 mg/dl, blood will be collected and sent to the clinical research center lab to make sure that the true blood sugar reading is not lower than what is seen on the bedside meter (requires approximately 1/10 teaspoon of blood). If a blood sugar of less than 60 mg/dl is found, the fast will end and blood will be collected through the IV line (small tube placed through the vein). The participant will be monitored by a nurse during the fast. She will check his blood pressure, pulse and respiratory rate periodically to make sure he is comfortable. After final blood collection, the participant will be allowed to feed normally and his IV will be removed. During the entire study, we expect to collect at least ¾ of a teaspoon of blood from the participant. No more than 1.2 teaspoons of blood will be collected from the participant during this entire study.
If a blood sugar less than 60 mg/dl is found at any time, blood will be drawn from a vein in the participant's arm and the study will end. He will then be allowed to eat. If he has a low blood sugar and is unable to feed the way he normally does, sugar water/gel may be given by mouth or sugar water may be given by the tube placed in his vein. If the participant normally is fed by a tube placed in his stomach, sugar water may be given through this tube.
- Conditions
- Prader Willi Syndrome, Hypoglycemia
- Being tested
- Infants with Prader-Willi Syndrome
- Keywords
- Prader Willi Syndrome, Hypoglycemia, Fasting study
- Medical subject headings
- Prader-Willi Syndrome, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants with Prader-Willi Syndrome | Infants between ages 2 to 12 months of age with Prader-Willi Syndrome. Receives: Other: Infants with Prader-Willi Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of hypoglycemia
We will determine whether fasting occurs within 6 hours of fasting in infants with Prader-Willi Syndrome
Measured: During 6 hours of fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader Willi SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Prader-Willi Research
- Responsible party
- Sponsor
- Investigators
- Jennifer L Miller, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897363
- Sponsor's protocol ID
- 59-2013
- Status last verified
- Sep 2014
- First submitted
- 8 Jul 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia in Prader-Willi Syndrome: A Prospective Study
- ClinicalTrials.gov ID
- NCT01897363
- Acronym / sponsor ID
- 59-2013
- Conditions
- Prader Willi Syndrome, Hypoglycemia
- Keywords
- Prader Willi Syndrome, Hypoglycemia, Fasting study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Foundation for Prader-Willi Research
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will include outpatient admission to the 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. A fast is when a person goes without food for a certain period of time. The participant will not be fasted longer than 6 hours.
The participant will arrive to the outpatient clinical research center at approximately 7am. A parent will be expected to stay with the participant at all times. The participant's finger will be poked for blood (requires approximately one drop of blood) soon after arrival to make sure his blood sugar is not already low. If the participant's blood sugar is low on arrival to the Clinical Research Center, additional blood will be drawn through his vein (a little more than half a teaspoon) and he will not have to complete the rest of the study. If his blood glucose is above 60 mg/dl, the participant will be given an opportunity to eat prior to starting the fast. A small tube will be placed in the participant's vein at the beginning of the fast to make additional blood draws easier. 1/10th a teaspoon of blood will be sent for cortisol testing when the IV is placed. Cortisol is a hormone that is important for control of blood sugar. In addition, the participant's finger will be pricked every hour for blood to monitor his blood sugar by bedside meter. Each finger prick will require approximately one to two drops of blood. A test to look at fat breakdown (ketones) will sometimes be checked using the same blood obtained when pricking the finger to check blood sugar. If a blood sugar of less than 70 mg/dl is found, blood sugars will be checked by finger prick every 30 minutes instead of every hour. If finger prick blood glucose is less than 65 mg/dl, blood will be collected and sent to the clinical research center lab to make sure that the true blood sugar reading is not lower than what is seen on the bedside meter (requires approximately 1/10 teaspoon of blood). If a blood sugar of less than 60 mg/dl is found, the fast will end and blood will be collected through the IV line (small tube placed through the vein). The participant will be monitored by a nurse during the fast. She will check his blood pressure, pulse and respiratory rate periodically to make sure he is comfortable. After final blood collection, the participant will be allowed to feed normally and his IV will be removed. During the entire study, we expect to collect at least ¾ of a teaspoon of blood from the participant. No more than 1.2 teaspoons of blood will be collected from the participant during this entire study.
If a blood sugar less than 60 mg/dl is found at any time, blood will be drawn from a vein in the participant's arm and the study will end. He will then be allowed to eat. If he has a low blood sugar and is unable to feed the way he normally does, sugar water/gel may be given by mouth or sugar water may be given by the tube placed in his vein. If the participant normally is fed by a tube placed in his stomach, sugar water may be given through this tube.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with Prader-Willi Syndrome | – | Other: Infants with Prader-Willi SyndromeInfants between ages 2 to 12 months of age with Prader-Willi Syndrome. |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with Prader-Willi Syndrome who have not yet started growth hormone therapy
Key inclusion criteria (3 listed)
- Diagnosed with Prader-Willi Syndrome
- Between ages 2-12 months of age
- Determined to be in nutritional phase 1a by clinical assessment
Key exclusion criteria (1 listed)
- Treatment with growth hormone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infants with Prader-Willi SyndromeParticipants 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. | Other | Infants with Prader-Willi Syndrome |
Primary outcome
Presence of hypoglycemia
Time frame: During 6 hours of fasting
We will determine whether fasting occurs within 6 hours of fasting in infants with Prader-Willi Syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Miller, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prader Willi Syndrome and Hypoglycemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of hypoglycemia (time frame: During 6 hours of fasting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.