Growth Hormone Deficiencyclamp-GHDNCT03525171
Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency
A study testing euglycemic hyperinsulinemic clamp in people with Growth Hormone Deficiency, run by University of Palermo at 1 site in Italy.
Trial summary
Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- euglycemic hyperinsulinemic clamp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 30 Dec 2015
- Phase
- Interventional
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Isolated idiopathic GH deficiency diagnosed by the auxological and biochemical criteria of the GH Research Society in prepubertal children
- Prepubertal children
Who cannot join
- Children with multiple hormone deficiency
- Children receiving other hormonal replacement treatment
- Pubertal children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Euglycemic Hyperinsulinemic Clamp and Surrogate Indexes of Insulin Sensitivity in Children With Growth Hormone Deficiency.
Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels.
The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.
Read the detailed description
The investigators aimed of this study was to use the hyperinsulinemic clamp to evaluate the impact of GH treatment on insulin-stimulated glucose utilization (M-value) in a group of children affected by GH deficiency and to compare the clamp-derived index with the most commonly used surrogate indexes of insulin sensitivity.
In all patients the auxological and metabolic evaluation was performed at baseline and after 12 months of GH treatment, while in controls these evaluations were only performed at baseline. In all children the investigators measured body height, body mass index (BMI) and waist circumference (WC). A blood sample was drawn after an overnight fast for the measurement of glucose, insulin, Hemoglobin A1c (HbA1c) and IGF-I. This sample served as the baseline for the oral glucose tolerance test (OGTT). Blood samples were collected every 30 min for 120 min for glucose and insulin measurements. As surrogate estimates of insulin sensitivity the investigators used the insulin sensitivity index, a composite index derived from the OGTT and validated by Matsuda and DeFronzo (ISI-Matsuda). On a different day, as a gold standard measurement of insulin sensitivity the investigators performed the euglycemic hyperinsulinemic clamp. As other insulin sensitivity markers, the serum levels of adiponectin and resistin after an overnight fast were also measured.
- Conditions
- Growth Hormone Deficiency
- Being tested
- euglycemic hyperinsulinemic clamp
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
euglycemic hyperinsulinemic clampDiagnostic test
In addition to auxological and baseline biochemical parameters, we performed the clamp to evaluate insulin sensitivity (M-value) at baseline (GHD group and controls) and after 12 months of GH treatment (GHD group).
| Study group | Role | What they receive |
|---|---|---|
| GHD children | Active comparator | 23 prepubertal children with isolated GHD consecutively admitted to the Section of Endocrinology of the University of Palermo during treated with GH for at least 12 months underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp Receives: Diagnostic Test: euglycemic hyperinsulinemic clamp |
| controls | Placebo comparator | 12 prepubertal healthy subjects with short stature recruited among children referred for assessment of short stature as a control group at baseline underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp Receives: Diagnostic Test: euglycemic hyperinsulinemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity in GHD children
insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity
Measured: baseline and after 12 months of GH treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Jan 2014
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We prospectively studied 23 prepubertal children with GH deficiency treated with GH for at least 12 months and 12 healthy subjects with short stature, matched for age and pubertal status
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Giordano, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525171
- Sponsor's protocol ID
- clamp-GHD
- Acronym
- clamp-GHD
- Status last verified
- May 2018
- First submitted
- 25 Oct 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available on request, to expand and contine the study
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Euglycemic Hyperinsulinemic Clamp and Surrogate Indexes of Insulin Sensitivity in Children With Growth Hormone Deficiency.
- ClinicalTrials.gov ID
- NCT03525171
- Acronym / sponsor ID
- clamp-GHD / clamp-GHD
- Conditions
- Growth Hormone Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 15 May 2018 (actual)
- 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.
Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels.
The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.
Detailed description
The investigators aimed of this study was to use the hyperinsulinemic clamp to evaluate the impact of GH treatment on insulin-stimulated glucose utilization (M-value) in a group of children affected by GH deficiency and to compare the clamp-derived index with the most commonly used surrogate indexes of insulin sensitivity.
In all patients the auxological and metabolic evaluation was performed at baseline and after 12 months of GH treatment, while in controls these evaluations were only performed at baseline. In all children the investigators measured body height, body mass index (BMI) and waist circumference (WC). A blood sample was drawn after an overnight fast for the measurement of glucose, insulin, Hemoglobin A1c (HbA1c) and IGF-I. This sample served as the baseline for the oral glucose tolerance test (OGTT). Blood samples were collected every 30 min for 120 min for glucose and insulin measurements. As surrogate estimates of insulin sensitivity the investigators used the insulin sensitivity index, a composite index derived from the OGTT and validated by Matsuda and DeFronzo (ISI-Matsuda). On a different day, as a gold standard measurement of insulin sensitivity the investigators performed the euglycemic hyperinsulinemic clamp. As other insulin sensitivity markers, the serum levels of adiponectin and resistin after an overnight fast were also measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We prospectively studied 23 prepubertal children with GH deficiency treated with GH for at least 12 months and 12 healthy subjects with short stature, matched for age and pubertal status
| Arm | Type | Receives |
|---|---|---|
| GHD children | Active comparator | Diagnostic Test: euglycemic hyperinsulinemic clamp23 prepubertal children with isolated GHD consecutively admitted to the Section of Endocrinology of the University of Palermo during treated with GH for at least 12 months underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp |
| controls | Placebo comparator | Diagnostic Test: euglycemic hyperinsulinemic clamp12 prepubertal healthy subjects with short stature recruited among children referred for assessment of short stature as a control group at baseline underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Isolated idiopathic GH deficiency diagnosed by the auxological and biochemical criteria of the GH Research Society in prepubertal children
- Prepubertal children
Key exclusion criteria (3 listed)
- Children with multiple hormone deficiency
- Children receiving other hormonal replacement treatment
- Pubertal children
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 |
|---|---|---|
| euglycemic hyperinsulinemic clampIn addition to auxological and baseline biochemical parameters, we performed the clamp to evaluate insulin sensitivity (M-value) at baseline (GHD group and controls) and after 12 months of GH treatment (GHD group). | Diagnostic test | GHD children, controls |
Primary outcome
Change in insulin sensitivity in GHD children
Time frame: baseline and after 12 months of GH treatment
insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity
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 15 May 2018.
- Individual participant dataSharing planned: Undecided. Data available on request, to expand and contine the study
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing euglycemic hyperinsulinemic clamp in people with Growth Hormone Deficiency, run by University of Palermo at 1 site in Italy.
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 2 inclusion and 3 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 15 May 2018. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Change in insulin sensitivity in GHD children (time frame: baseline and after 12 months of GH treatment). 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 15 May 2018.