ObesityNIFOBNCT04116229

Cognition and Magnetic Resonance Imaging of Brain Inflammation in Obesity

A study testing Oral glucose tolerance test, Cognitive testing and Magnetic resonance imaging in people with Obesity, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Oral glucose tolerance test, Cognitive testing and Magnetic resonance imaging
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 19 Mar 2019to 30 Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Non-obese (body mass index = 18 - 25 kg/m^2) or Obese (body mass index ≥ 30 kg/m^2
Any race or ethnicity
Native English speaker

Who cannot join

Past or current diabetes
Current psychotropic medication use
Past or current neurological illness
Past or current substance or alcohol misuse
Past or current mental illness
Current binge eating disorder

Show all 11Show fewer

Magnetic resonance imaging contraindications
Pregnancy
Currently lactating
Tobacco use within past month
Over 350 lb

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Neuroinflammation in Obesity

The rate of obesity in the United States is high and is a risk factor for concurrent cognitive impairment and, in late life, dementias such as Alzheimer's disease. In order to prevent or reduce cognitive impairment, the mechanism underlying the link between obesity and cognitive impairment must be understood. The current study aims to provide preliminary data on whether brain inflammation occurs in obesity and relates to cognitive deficits using magnetic resonance neuroimaging and cognitive testing. It is hypothesized that obese individuals will have greater brain inflammation and lower cognitive function compared to normal-weight individuals. Further, it is predicted that brain inflammation will relate to cognitive function and plasma indicators of inflammation in obese individuals.

Read the detailed description

Initially, normal-weight or obese potential participants are screened by a phone interview that assesses medical history. Obtainment of informed consent and further screening occurs on the day of the study visit. Participants then undergo a 2 hour oral glucose tolerance test (OGTT) including blood draws for metabolic and inflammatory marker levels in plasma. Lunch is then provided. Participants are then administered 30 minute computer-based cognitive testing from the NIH Toolbox Cognition Battery. After cognitive testing, participants undergo 1.5 hour magnetic resonance imaging (MRI) that includes structural, diffusion tensor, and functional MR imaging.

Conditions: Obesity
Being tested: Oral glucose tolerance test, Cognitive testing, Magnetic resonance imaging
Keywords: Obesity, Inflammation, Cognitive impairment, Neuroimaging, Magnetic resonance imaging
Medical subject headings: Obesity, Inflammation, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral glucose tolerance testProcedure or surgery
After 8 hours fasting overnight, an intravenous catheter is placed in the arm or hand for blood draws. Participants drink 75 grams of an oral glucose drink after baseline blood samples are drawn. More blood draws occur at 10, 20, 30, 60 and 120 min post-glucose drink.
Cognitive testingBehavioural
For approximately 40 minutes, participants are assessed for cognitive function using computer-based tests available from the NIH Toolbox Cognitive Battery (Weintraub et al., 2013), including attention and executive functioning, episodic memory, working memory, language, processing speed, and immediate recall.
Magnetic resonance imagingProcedure or surgery
Magnetic resonance imaging (MRI) scans will be performed in a 3 Tesla MRI scanner over 1.5 hours. Participants will be asked to lay down flat on their backs and to try to stay still throughout the MRI scan. The participant will wear MRI-safe headphones to block out noise due to the MRI scans. Participant comfort will be verbally checked on throughout the scan and the participant will be provided with a 'squeeze ball' to signal the MRI technician that they want to get out of the scanner immediately.

Study groups in NCT04116229
Study group	Role	What they receive
Normal-weight	Active comparator	Participants who have a body mass index within the normal-weight category. Receives: Procedure: Oral glucose tolerance test; Behavioral: Cognitive testing; Procedure: Magnetic resonance imaging
Obese	Active comparator	Participants who have a body mass index within the obese category. Receives: Procedure: Oral glucose tolerance test; Behavioral: Cognitive testing; Procedure: Magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI)
Diffusion Basis Spectrum Imaging (Cross and Song, 2017) is a computational method that will be applied to diffusion tensor images of the brain to estimate putative inflammation-related markers including cellularity and edema in obese and normal-weight individuals. DBSI metrics are quantitative but unitless. Cellularity and edema fractions of the total diffusion signal (including axial, radial, restricted (cellularity) and hindered (edema)) will be estimated in brain white matter tracts.
Measured: 1.5 hours at the end of one (up to) 8 hour study day that includes all outcome measures
Cognitive Function in Obese and Normal-weight Individuals as Measured by the National Institutes of Health (NIH) Toolbox Cognitive Battery and DBSI Putative Neuroinflammation Metrics
Cognitive performance including fluid and crystallized cognition composite T-scores from computer-based NIH Cognitive Toolbox assessments (Weintraub et al., 2013) will be assessed in obese and normal-weight individuals. These T-scores will include scores from tasks that assess attention and executive functioning, episodic memory, working memory, language, processing speed, and immediate recall (see NIH Toolbox Cognitive Battery website). T-scores are corrected for socioeconomic status and their distribution has a mean of 50 and a standard deviation of 10. Higher T-scores indicate better cognitive function. T-scores will be correlated with DBSI-assessed neuroinflammation metrics including restricted fraction (DBSI RF, putative cellularity) and hindered fraction (DBSI HF, putative vasogenic edema) in brain white matter tracts.
Measured: 40 minutes during one (up to) 8 hour study day that includes all outcome measures; after OGTT and prior to MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201930 Oct 2020

First posted4 Oct 2019
Study start19 Mar 2019
Primary completion30 Oct 2020
Study completion30 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Model description: This study employed a single group model in which participants with obesity and participants with normal-weight underwent magnetic resonance imaging, blood draws and cognitive assessment.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04116229
Sponsor's protocol ID: 201805053
Other IDs: P30DK020579
Acronym: NIFOB
Status last verified: Mar 2023
First submitted: 2 Oct 2019
Last updated: 10 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
PubMed 23479546
Cross AH, Song SK. "A new imaging modality to non-invasively assess multiple sclerosis pathology". J Neuroimmunol. 2017 Mar 15;304:81-85. doi: 10.1016/j.jneuroim.2016.10.002. Epub 2016 Oct 8.
PubMed 27773433
Breda E, Cavaghan MK, Toffolo G, Polonsky KS, Cobelli C. Oral glucose tolerance test minimal model indexes of beta-cell function and insulin sensitivity. Diabetes. 2001 Jan;50(1):150-8. doi: 10.2337/diabetes.50.1.150.
PubMed 11147781

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuroinflammation in Obesity
ClinicalTrials.gov ID: NCT04116229
Acronym / sponsor ID: NIFOB / 201805053
Conditions: Obesity
Keywords: Obesity, Inflammation, Cognitive impairment, Neuroimaging, Magnetic resonance imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 19 Mar 2019 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 30 Oct 2020 (actual)
First posted: 4 Oct 2019 (actual)
Results: Posted 19 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: This study employed a single group model in which participants with obesity and participants with normal-weight underwent magnetic resonance imaging, blood draws and cognitive assessment.

Arm	Type	Receives
Normal-weight	Active comparator	Procedure: Oral glucose tolerance test, Behavioral: Cognitive testing, Procedure: Magnetic resonance imagingParticipants who have a body mass index within the normal-weight category.
Obese	Active comparator	Procedure: Oral glucose tolerance test, Behavioral: Cognitive testing, Procedure: Magnetic resonance imagingParticipants who have a body mass index within the obese category.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Non-obese (body mass index = 18 - 25 kg/m^2) or Obese (body mass index ≥ 30 kg/m^2
Any race or ethnicity
Native English speaker

Key exclusion criteria (11 listed)

Past or current diabetes
Current psychotropic medication use
Past or current neurological illness
Past or current substance or alcohol misuse
Past or current mental illness

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
Oral glucose tolerance testAfter 8 hours fasting overnight, an intravenous catheter is placed in the arm or hand for blood draws. Participants drink 75 grams of an oral glucose drink after baseline blood samples are drawn. More blood draws occur at 10, 20, 30, 60 and 120 min post-glucose drink.	Procedure or surgery	Normal-weight, Obese
Cognitive testingFor approximately 40 minutes, participants are assessed for cognitive function using computer-based tests available from the NIH Toolbox Cognitive Battery (Weintraub et al., 2013), including attention and executive functioning, episodic memory, working memory, language, processing speed, and immediate recall.	Behavioural	Normal-weight, Obese
Magnetic resonance imagingMagnetic resonance imaging (MRI) scans will be performed in a 3 Tesla MRI scanner over 1.5 hours. Participants will be asked to lay down flat on their backs and to try to stay still throughout the MRI scan. The participant will wear MRI-safe headphones to block out noise due to the MRI scans. Participant comfort will be verbally checked on throughout the scan and the participant will be provided with a 'squeeze ball' to signal the MRI technician that they want to get out of the scanner immediately.	Procedure or surgery	Normal-weight, Obese

Primary outcome

Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI)
Time frame: 1.5 hours at the end of one (up to) 8 hour study day that includes all outcome measures
Diffusion Basis Spectrum Imaging (Cross and Song, 2017) is a computational method that will be applied to diffusion tensor images of the brain to estimate putative inflammation-related markers including cellularity and edema in obese and normal-weight individuals. DBSI metrics are quantitative but unitless. Cellularity and edema fractions of the total diffusion signal (including axial, radial, restricted (cellularity) and hindered (edema)) will be estimated in brain white matter tracts.
Cognitive Function in Obese and Normal-weight Individuals as Measured by the National Institutes of Health (NIH) Toolbox Cognitive Battery and DBSI Putative Neuroinflammation Metrics
Time frame: 40 minutes during one (up to) 8 hour study day that includes all outcome measures; after OGTT and prior to MRI
Cognitive performance including fluid and crystallized cognition composite T-scores from computer-based NIH Cognitive Toolbox assessments (Weintraub et al., 2013) will be assessed in obese and normal-weight individuals. These T-scores will include scores from tasks that assess attention and executive functioning, episodic memory, working memory, language, processing speed, and immediate recall (see NIH Toolbox Cognitive Battery website). T-scores are corrected for socioeconomic status and their distribution has a mean of 50 and a standard deviation of 10. Higher T-scores indicate better cognitive function. T-scores will be correlated with DBSI-assessed neuroinflammation metrics including restricted fraction (DBSI RF, putative cellularity) and hindered fraction (DBSI HF, putative vasogenic edema) in brain white matter tracts.

Results and safety

Results posted to the registry on 19 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal-weight	10	8
Obese	10	6

Primary outcome: Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI)

Time frame: 1.5 hours at the end of one (up to) 8 hour study day that includes all outcome measures. Mean (Standard Deviation). Unit: unitless

Measure	Normal-weight n = 8	Obese n = 6
DBSI restricted fraction (cellularity)	.0468 (.0024)	.0492 (.0034)
DBSI hindered fraction (vasogenic edema)	.176 (.013)	.186 (.014)

Normal-weight vs Obese: Median Difference (Final Values): 0.05, p = 0.28, Independent-Samples Median Test
Normal-weight vs Obese: Median Difference (Final Values): 0.18, p = 0.03, Independent-Samples Median Test

Population analysed: Data from 8 individuals with normal-weight and 6 individuals with obesity were included in baseline analyses. Five individuals were enrolled in the study but their data was not collected due to meeting exclusion criteria. One individual was enrolled but could not be scheduled for the study and therefore did not contribute data.

Primary outcome: Cognitive Function in Obese and Normal-weight Individuals as Measured by the National Institutes of Health (NIH) Toolbox Cognitive Battery and DBSI Putative Neuroinflammation Metrics

Time frame: 40 minutes during one (up to) 8 hour study day that includes all outcome measures; after OGTT and prior to MRI. Mean (Standard Deviation). Unit: T-score

Measure	Normal-weight n = 6	Obese n = 6
Crystallized Cognition	60.3 (6.9)	53.3 (9.0)
Fluid Cognition	54.4 (6.7)	59.3 (7.4)

Normal-weight vs Obese: Slope: -0.69, p = 0.01, Regression, Linear
Normal-weight vs Obese: Slope: 0.52, p = 0.10, Regression, Linear
Normal-weight vs Obese: Slope: -0.45, p = 0.01, Regression, Linear

Population analysed: Two individuals in the normal-weight group were not native English speakers and their cognitive data is not included. A complete set of fluid cognition measures was not collected from one normal-weight participant and their fluid cognition data is not included.

Adverse events

Time frame: Over one study visit, about 8 hours per participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal-weight	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Obese	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): An early anticipated enrollment table specified a total of 8 individuals. Due to necessary change in study methods, we were able to increase the anticipated enrollment to 20 individuals. 20 individuals were enrolled but 5 met exclusion criteria during further screening (after signing informed consent) and one could not be scheduled due to scheduling conflicts (but they had signed the consent form). In total, we had complete datasets from 14 enrolled individuals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23479546Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
Background: PubMed 27773433Cross AH, Song SK. "A new imaging modality to non-invasively assess multiple sclerosis pathology". J Neuroimmunol. 2017 Mar 15;304:81-85. doi: 10.1016/j.jneuroim.2016.10.002. Epub 2016 Oct 8.
Background: PubMed 11147781Breda E, Cavaghan MK, Toffolo G, Polonsky KS, Cobelli C. Oral glucose tolerance test minimal model indexes of beta-cell function and insulin sensitivity. Diabetes. 2001 Jan;50(1):150-8. doi: 10.2337/diabetes.50.1.150.
Individual participant dataSharing planned: Yes

Related trials for Obesity

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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.

Tamara Hershey, PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oral glucose tolerance test, Cognitive testing and Magnetic resonance imaging in people with Obesity, run by Washington University School of Medicine 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 11 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 10 Mar 2023. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI) (time frame: 1.5 hours at the end of one (up to) 8 hour study day that includes all outcome measures). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116229, which also lists 3 linked publications.

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 10 Mar 2023.