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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 22, 2005 | ||||||||
| Last Updated Date | November 18, 2009 | ||||||||
| Start Date ICMJE | April 2005 | ||||||||
| Estimated Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
The primary outcome is to establish that XSCID patients treated with IGF-1 do not experience more than the expected rate of drug-related adverse events than non-XSCID children receiving IGF-2 therapy, which is estimated at 5 percent. | ||||||||
| Change History | Complete list of historical versions of study NCT00109174 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
The primary objective is to evaluate the safety of treating XSCID children with growth failure using IGF-1. The secondary objective is to evaluate the efficacy of IGF-1 treatment for growth failure in children with XSCID. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | MRS Measurement of Glutamate and GABA Metabolism in Brain | ||||||||
| Official Title ICMJE | MRS (Magnetic Resonance Spectroscopy) Measurement of Glutamate and GABA Metabolism in Brain | ||||||||
| Brief Summary | This study will use magnetic resonance spectroscopy (MRS) to measure in the brain the transfer of [13]C as it is naturally metabolized from glucose to specific chemical transmitters. From this method, we can measure the rate of production of an important excitatory neurotransmitter (glutamate) as well as an inhibitory neurotransmitter (GABA). |
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| Detailed Description | (13)C is a stable (i.e., non-radioactive) isotope of carbon with a natural abundance of approximately 1%. Following infusion of [(13)C]glucose and/or [(13)C]acetate, in vivo MRS (magnetic resonance spectroscopy) can monitor the rate of flux of the (13)C atom from glucose and/or acetate to glutamate to glutamine. Thus, this procedure can provide measure of glutamate (GLU) and glutamine (GLN) turnover in brain. We have established parameters to obtain these measurements in nonhuman primate brain. The current protocol seeks approval to optimize MRS parameters for human brain using the GE 3T device. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment | ||||||||
| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | Procedure: Magnetic Resonance Spectroscopy | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | March 2006 | ||||||||
| Estimated Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Age: 18-65 years Diagnosis: Healthy EXCLUSION CRITERIA: Serious medical illness (including diabetes) as determined from H& P or laboratory testing Prescription psychotropic medication; drug free period must be greater than 3 weeks for anticholinergics and benzodiazepine and greater than 8 weeks for fluoxetine, antipsychotics, anticonvulsants Claustrophobia Pregnancy; women with child bearing potential will have pregnancy test to exclude pregnancy Any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.) Unable to lay on one's back for MRI/MRS scans Positive HIV test |
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00109174 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 050144, 05-M-0144 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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