- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077579
Imaging Biomarkers in Obesity
Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Cyrus Raji, MD, PhD
- Phone Number: 314-273-0334
- Email: craji@wustl.edu
Study Contact Backup
- Name: Nancy Hantler, BS, CCRC, ACRP-PM
- Phone Number: 314-362-7315
- Email: hantlern@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- LaKisha A Lloyd, MS
- Phone Number: 314-362-7315
- Email: lloydl@wustl.edu
-
Contact:
- Nancy A Hantler, BS
- Phone Number: 3143627315
- Email: hantlern@wustl.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female, 40-60 years of age and any race;
- MMSE = or greater than 25 or a Clinical Dementia Rating Scale (CDR)=0;
- Willing and able to undergo MRI
- Willing to complete PET scans, including [11C]PiB and 18F-AV-1451 (Flortaucipir) radioactive tracer injection under protocols IRB #201409014 & 201906028
Willing to participate in the metabolic subtyping of metabolically normal or abnormal overweight or obese status for the following three groups:
a. Group 1: MAOO criteria: i. BMI ≥25 but <45 kg/m2; ii. Maximum body circumference < 165 cm to ensure participants fit into the PET/CT and MR scanners; iii. Fasting blood glucose: ≥100 mg/dl or blood glucose 2 h after an OGTT: ≥140 or fasting insulin: >20 µu/ml;
b. Group 2: MNOO criteria: i. BMI ≥ 25 but <45 kg/m2; ii. Maximum body circumference < 165 cm to ensure participants fit into the PET/CT and MR scanners; iii. Blood glucose 2 h after an OGTT: iv. HbA1c < 5.7% v. Fasting insulin: < 20 µu/ml;
c. Group 3: MNLP criteria: i. BMI ≥18.5 but < 25.0 kg/m2; ii. Maximum body circumference < 165 cm to ensure subjects fit into the PET/CT and MR scanners; iii. Fasting blood glucose: < 100 mg/dl; iv. Blood glucose 2 h after an OGTT: < 140 mg/dl; v. HbA1c < 5.7% vi. Fasting insulin: < 20 µu/ml;
Exclusion Criteria:
- Any condition that in the opinion of the Investigator or designee could increase the risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data, (e.g., currently taking a drug for treatment of obesity);
- Intend to have bariatric surgery;
- Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain);
- Severe claustrophobia;
- Women who are currently pregnant or breast-feeding;
- Currently receiving an active obesity study drug (or placebo) or in an obesity clinical trial;
- Laboratory Evaluations exclusion: • Oral glucose tolerance test should not be performed in patients who already fulfill the criteria for diabetes mellitus. These include: - History of Type 1 or 2 diabetes mellitus - Prior documentation of a fasting plasma glucose >7.0 mmol/L or two or more occasions or clinical symptoms of diabetes e.g. polydipsia, polyuria, ketonuria and rapid weight loss with a random plasma glucose of >11.1 mmol/L • Other contraindications for venous access as part of OGTT or blood draws: - Venous fibrosis or shunt grafts in both upper extremities - Ongoing cellulitis or infection, particularly in the upper extremities. - Presence of a hematoma at the site of vascular access. - History of hypoglycemic encephalopathy that can occur with prolonged fasting
- MRI exclusion: • Contraindications to MRI (e.g., certain incompatible electronic medical devices that make it potentially unsafe for the individual to participate). All participants must be willing to undergo at least two MRI screenings, supervised by Level II MRI personnel as designated by the American College of Radiology (ACR).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
metabolically abnormal overweight & obese
|
metabolically normal overweight
|
obese and metabolically normal lean
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aim - increased atrophy in MAOO compared to MNOO and MNLP participants
Time Frame: 10 hours
|
we hypothesize increased atrophy in MAOO compared to MNOO and MNLP particularly in regions important for AD pathology such as the hippocampus and hippocampal sub-regions.
These will be measured through the results of the blood tests, MRI scan & data from the PET scans.
|
10 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aim 2- higher burden of white matter neuroinflammation on DBSI
Time Frame: 10 hours
|
We hypothesize a higher burden of white matter neuroinflammation on DBSI in MAOO in relation to other overweight and obese groups.
The MRI scan will be used to measure these outcomes.
|
10 hours
|
Aim 3-increased amyloid and tau deposition on brain
Time Frame: 10 hours
|
We hypothesize increased amyloid and tau deposition on brain PET in MAOO versus other groups.
The PET scan data will be used to measure these outcomes.
|
10 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sub-aims-sex differences in atrophy and neuroinflammation
Time Frame: 10 hours
|
Will examine sex differences in atrophy and neuroinflammation.
We will also investigate sex differences in amyloid and tau deposition across the overweight/obese and lean groups.
These will be measured through the results of the blood tests, MRI scan & data from the PET scans.
|
10 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cyrus Raji, MD, PhD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202102186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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