- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02733120
Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder (ASD)
Study on Metabolic Processes and Cognitive Functions in Adults and Adolescents With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigates the metabolic profile of different amino acids and cognitive functions in adults and adolescents with ASD in comparison with age- and gender-matched healthy young adults. The study involves 1 screening visit of approximately 2 hours and 1 study day of 5 hours
The objective is to explore changes in amino acids (e.g. TRP pathway) in ASD and evaluate the function of TRP in neuropsychological functions by using the technique of stable isotope and our newly developed 'single pulse method' with multiple amino acid and keto-acid isotopes.
The aim of this study is to determine the underlying mechanism by which the metabolism of amino acids such as TRP are involved in mood and cognitive functions in ADS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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College Station, Texas, United States, 77843
- Texas A&M University-CTRAL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria Healthy:
- Healthy male or female according to the investigator's or appointed staff's judgment
- Age 16 years or older
- Ability to walk, sit down and stand up independently
- Ability to lie in supine or elevated position for 4 hours
- Willingness and ability to comply with the protocol
Inclusion criteria subjects with Autism Spectrum Disorder (ASD):
- Healthy high functioning person diagnosed with autism spectrum disorder
- Age 16 years or older
- Ability to walk, sit down and stand up independently
- Ability to lie in supine or elevated position for 4 hours
- Willingness and ability to comply with the protocol
Exclusion Criteria:
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy group)
- Failure to give informed consent
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- Metabolic diseases, including hepatic or renal disorders
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Pre-planned surgery of procedures that would interfere with the conduct of the study
- Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
- Current alcohol or drug abuse
- Use of protein or amino acid containing nutritional supplements within 5 days prior to the study days
- Use of long-term oral corticosteroids or short course of oral cortico-steroids 4 weeks preceding first test day
- Body Mass Index of < 18.5 or ≥ 40 kg/m2
- Montreal Cognitive Assessment score of < 20
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy matched controls
Study Day: The subject will arrive fasted.
A catheter will be inserted in the arm for stable isotope infusion and blood sampling.
The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air.
Immediately after a baseline blood sample is taken, an infusion with stable isotopes will be administered by the research nurse.
Stable isotopes are given to measure amino acid metabolism.
Blood samples will be collected before and/or after infusion.
Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet.
|
stable isotopes such as 15N2, TRP, 2H3-Leucine, L-[2H3]-3-Methylhistidine, 2H2-Glycine, 2-D-hydroxyproline, 1-13C-ketoisocaproic acid (KIC), L-[Guanido-15N2]-Arginine, L-[ureido-13C-2H2]-Citrulline), L-Glutamine-amide-15N, 1,2-13C2-L-Glutamic acid, 1,2-13C2Taurine, and 13C-Urea is given IV simultaneously
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Experimental: Adults with Autism Spectrum Disorder
The subject will arrive fasted.
A catheter will be inserted in the arm for stable isotope infusion and blood sampling.
The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air.
Immediately after a baseline blood sample is taken, an infusion with stable isotopes will be administered by the research nurse.
Stable isotopes are given to measure amino acid metabolism.
Blood samples will be collected before and/or after infusion.
Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet.
|
stable isotopes such as 15N2, TRP, 2H3-Leucine, L-[2H3]-3-Methylhistidine, 2H2-Glycine, 2-D-hydroxyproline, 1-13C-ketoisocaproic acid (KIC), L-[Guanido-15N2]-Arginine, L-[ureido-13C-2H2]-Citrulline), L-Glutamine-amide-15N, 1,2-13C2-L-Glutamic acid, 1,2-13C2Taurine, and 13C-Urea is given IV simultaneously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tryptophan turnover
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
leucine turnover
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
|
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Whole body myofibrillar protein breakdown rate (reflecting muscle protein breakdown)
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
|
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glutathione turnover
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
|
|
hydroxyproline breakdown (reflecting collagen breakdown)
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
|
2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
|
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glutamate turnover
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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taurine turnover
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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urea production
Time Frame: 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
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2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes
|
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Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS),
Time Frame: 1 day
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a fourteen item self-assessment scale.
Seven of the items related to anxiety and seven relate to depression.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.
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1 day
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Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
Time Frame: 1 day
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Auditory Verbal Learning Test (AVLT): a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information.
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1 day
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Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),
Time Frame: 1 day
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ontrolled Oral Word Association Test (COWAT): The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet.
The task contains three trials.
Measures phonetic verbal fluency.
The raw score (total and mean words recorded across the three trials) was reported.
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1 day
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Group differences in learning and memory as measured by Digit Span
Time Frame: 1 day
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recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward).
Measures auditory attention and verbal working memory.
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1 day
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Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Time Frame: 1 day
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assesses several cognitive domains and is used for the screening of mild cognitive impairment.
Total scores range from 0-30 with lower scores indicating decreased functioning.
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1 day
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Group differences in attention and executive functions as measured by Trail Making Test (TMT),
Time Frame: 1 day
|
In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy.
In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy.
Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility.
The total time in seconds was reported for each measure.
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1 day
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Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),
Time Frame: 1 day
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a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match.
The examinee reads the words or names the ink colors as quickly as possible within a time limit.
Measures selective attention and inhibitory control.
The total time in seconds was reported for each trial.
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1 day
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Adolescent/Adult Sensory Profile
Time Frame: 1 day
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a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.
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1 day
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Group differences in attention and executive functions as measured by Brief-A
Time Frame: 1 day
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a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
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1 day
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Group differences in attention and executive functions as measured by PASAT
Time Frame: 1 day
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a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
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1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0542
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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