Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder - Clinical Trial for Autism Spectrum Disorder | NCT02733120

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stable isotope infusion

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Texas A&M University-CTRAL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy matched controls

Adults with Autism Spectrum Disorder

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tryptophan turnover

Secondary Outcome Measures

leucine turnover

Whole body myofibrillar protein breakdown rate (reflecting muscle protein breakdown)

glutathione turnover

hydroxyproline breakdown (reflecting collagen breakdown)

glutamate turnover

taurine turnover

urea production

Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS),

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.

Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)

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.

Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),

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.

Group differences in learning and memory as measured by Digit Span

recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory.

Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)

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.

Group differences in attention and executive functions as measured by Trail Making Test (TMT),

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.

Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),

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.

Adolescent/Adult Sensory Profile

a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.

Group differences in attention and executive functions as measured by Brief-A

a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.

Group differences in attention and executive functions as measured by PASAT

a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.

Full Information

NCT ID

NCT02733120

First Posted

February 1, 2016

Last Updated

January 14, 2019

Sponsor

Texas A&M University

1. Study Identification

Unique Protocol Identification Number

NCT02733120

Brief Title

Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder

Acronym

ASD

Official Title

Study on Metabolic Processes and Cognitive Functions in Adults and Adolescents With Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas A&M University

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The objective of this study is to gain preliminary information and knowledge on metabolic profile in ASD. The benefit of this study will be to expand our insight of the potential relationship in metabolic processes and neuropsychological functions in ASD. For example, based on the obtained data of the study we can determine whether there is a link between the tryptophan pathway and cognitive functions in autism. The project is based on a systematic and multidisciplinary approach using tracers for delineating the mechanism by which the metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD. Using an innovative approach to the evaluation of amino acids has not been used in adults with ASD. In addition, the obtained data of the study holds promise to develop specific markers (metabolic and/or neuropsychological) for guiding the identification those individuals with increased risk of developing mood disturbances or cognitive impairment, and for predicting the therapeutic effect of a specific nutritional interventions in subjects with ASD.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy matched controls

Arm Type

Experimental

Arm Description

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.

Arm Title

Adults with Autism Spectrum Disorder

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

stable isotope infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Tryptophan turnover

Time Frame