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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05553405
Other study ID # 2000031993
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 1, 2024
Est. completion date January 1, 2033

Study information

Verified date June 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim 1: To measure levels of microglia using the radiotracer [11C]PBR28 and PET brain imaging in obese (n=50) vs. lean individuals (n=50). The investigators will recruit 100 subjects who will participate in a single [11C]PBR28 scan to measure levels of TSPO, a marker of microglia. Aim 2: To determine differences in brain functional connectivity at rest and in response to a decision- making task in obese (n=50) vs. lean individuals (n=50) using fMRI imaging. The same subjects from Aim 1 will participate in a resting state functional magnetic resonance imaging (fMRI) followed by a decision making task during fMRI acquisition. Aim 3: To assess whether acute elevation of lipid levels through intralipid infusion in lean, healthy individuals (n=20) will induce microglial activation. 20 lean individuals will be recruited to participate in a paradigm that includes a baseline [11C]PBR28 scan, an infusion of intralipid, and a second [11C]PBR28 scan approximately 4 hours post intralipid infusion. The investigators will attempt to utilize subjects from aim 1 in order to use their baseline scans for this paradigm. Aim 4: To determine whether there are differences in levels of microglia between individuals with and without type 1 diabetes (n=20). 20 patients with diabetes (type 1 diabetes or type 2 diabetes)will be recruited to participate in a single [11C]PBR28 scan to compare to Aim 1 participants.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2033
Est. primary completion date January 1, 2033
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Age 18-55 years - Able to read and write English and provide voluntary informed consent - Physically and psychiatrically healthy by medical history, physical, psychiatric, neurological, EKG and laboratory examinations - For Aims 1-3: HbA1C < 5.7% - For Aim 4: HbA1C >6.5% and known diagnosis of T1DM or T2DM Exclusion Criteria: - Abnormal labs including Creatinine>1.5mg/dL, Hematocrit < 35% for females and < 39% for males, ALT/AST >2.5X upper limit of normal, abnormal TSH - Known significant thyroid, hepatic, neurologic, psychiatric, cerebrovascular, or cardiovascular disease - >5% body weight change in last 6 months - Current or recent regular steroid use in last 6 months, illicit drug use that is deemed to interfere with results including problematic alcohol use as defined by NIAAA - Current regular use of psychotropic and/or potentially psychoactive prescription medications - Regular use of any vitamins/supplements that could affect lipids - Current regular use of non-steroidal anti-inflammatory medications, statins, or lipid lowering agents - Vaccination in the last month - Individuals who are classified as "low binders" for the rs6971 polymorphism (<10% of the population) - For females, physical or laboratory (-HCG) evidence of pregnancy, seeking pregnancy, or lactating. A urine drug screen and pregnancy test will be performed at screening and prior to the imaging session. Subjects who screen positive will be excluded. Note: If a subject tests positive for an illicit substance, the PI will determine if the substance would interfere with the results and may terminate participation if applicable. Results of the test would only be noted in the subjects de-identified chart to document the occurrence.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intralipid Infusion
Intralipid 20% (a 20% IV fat emulsion) is a sterile, non-pyrogenic fat emulsion prepared for IV administration as a source of calories and essential fatty acids. It is made up of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin and water for injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8.

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline [11C]PBR28 VT values [11C]PBR28 VT values in our primary regions of interest (PFC and hippocampus) from PET Scan. Linear mixed-effect models will be conducted to evaluate differences in [11C]PBR28 VT values between lean, healthy controls (n=40) and individuals with obesity (n=40), controlling for rs6971 genotype, age, and sex. At baseline
Primary Post-Intralipid [11C]PBR28 VT values [11C]PBR28 VT values in our primary regions of interest (PFC and hippocampus) from PET Scan. Linear mixed-effect models will be conducted to evaluate differences in [11C]PBR28 VT values between lean, healthy controls (n=40) and individuals with obesity (n=40), controlling for rs6971 genotype, age, and sex. Approximately 3 Hours After Intralipid Infusion
Primary Baseline Functional Connectivity ICD values will be obtained from primary a priori regions of interest (vmPFC and hippocampus) with PET Scan. Independent t-tests will be used to compare the ICD data between the study groups. At baseline
Primary Post-Intralipid Functional Connectivity ICD values will be obtained from primary a priori regions of interest (vmPFC and hippocampus) with PET Scan. Independent t-tests will be used to compare the ICD data between the study groups. Approximately 3 Hours After Intralipid Infusion
Primary Baseline Microglial Activation Regional [11C]PBR28 VT values from pre-lipid infusion PET Scan At baseline
Primary Post-Intralipid Microglial Activation Percent change in regional [11C]PBR28 VT values from pre-lipid infusion PET Scan to post-lipid infusion PET Scan will be calculated across brain regions. Increased microglial activation will be measured as a 20% or more increase in TSPO levels from scan 1 to scan 2 Approximately 3 Hours After Intralipid Infusion
Secondary Baseline Visual Attention Visual attention: response latency to identify card color (log10(ms); higher ~ worse attention). At baseline
Secondary Post-Intralipid Infusion Visual Attention Visual attention: response latency to identify card color (log10(ms); higher ~ worse attention). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Visual Learning Visual learning: % of correctly identified repeat cards (arcsine(% correct); higher values ~ better learning). At baseline
Secondary Post-Intralipid Infusion Visual Learning Visual learning: % of correctly identified repeat cards (arcsine(% correct); higher values ~ better learning). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Verbal Memory Verbal memory: # of correctly recalled items from a grocery list (3 trials). Verbal recall: # of correctly recalled items from a grocery list after a delay (1 trial; higher ~ better memory/recall). At baseline
Secondary Post-Intralipid Verbal Memory Verbal memory: # of correctly recalled items from a grocery list (3 trials). Verbal recall: # of correctly recalled items from a grocery list after a delay (1 trial; higher ~ better memory/recall). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Executive Function Executive function: number of errors navigating a 'hidden' maze (5 trials; higher ~ worse executive function). At baseline
Secondary Post-Intralipid Executive Function Executive function: number of errors navigating a 'hidden' maze (5 trials; higher ~ worse executive function). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Visual-Motor Processing Speed Visual-motor processing speed: response latency to detect a card flipped over (log10(ms); higher ~ worse processing speed). At baseline
Secondary Post-Intralipid Visual-Motor Processing Speed Visual-motor processing speed: response latency to detect a card flipped over (log10(ms); higher ~ worse processing speed). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Working Memory Working memory: % of correctly identified cards that matched the card presented either one- or two-cards previously (arcsine(% correct); higher ~ better working memory). At baseline
Secondary Post-Intralipid Working Memory Working memory: % of correctly identified cards that matched the card presented either one- or two-cards previously (arcsine(% correct); higher ~ better working memory). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Social Cognition Social cognition: response latency to identify the mismatched facial expression based on its emotional content (ms; log10; higher ~ worse social cognition). At baseline
Secondary Post-Intralipid Social Cognition Social cognition: response latency to identify the mismatched facial expression based on its emotional content (ms; log10; higher ~ worse social cognition). Approximately 1 Hour After Intralipid Infusion
Secondary Baseline Reward Responsiveness Reward responsiveness will be quantified via computerized Probabilistic Reward Task At baseline
Secondary Post-Intralipid Reward Responsiveness Reward responsiveness will be quantified via computerized Probabilistic Reward Task Approximately 1 Hour After Intralipid Infusion
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