ObesityNCT04946552
Sympathetic Activation in Obesity
A study testing PET Scan, Mixed Meal Test and Muscle sympathetic nerve activity (MSNA) in people with Obesity and Healthy, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether sympathetic nervous system (SNS) activity in white adipose tissue (WAT) and brown adipose tissue (BAT), skeletal muscle and brain is altered in individuals with obesity in comparison to individuals with normal weight. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- PET Scan, Mixed Meal Test and Muscle sympathetic nerve activity (MSNA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2021to 30 Sep 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Hypertension
- Cardiac or pulmonary disease,
- Known history of Type 1 or Type 2 diabetes
- Hepatic disease, swallowing and gastrointestinal disorders
- Current use of anti-obesity medications, supplements and/or anti-hyperglycemic medications
Show all 15Show fewer
- Neurological injury or illness, and psychiatric medications
- Women who are pregnant or lactating
- Subjects who suffer from claustrophobia
- Subjects who have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to participation in this study
- Radiation works or participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits.
- Subjects with history of IV drug use which would prevent venous access for PET tracer injection
- Severe motor problems that prevent the subject from lying still for PET and MR imaging
- Subjects who complain of chronic pain
- Blood donation within 8 weeks of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Church Street Research Unit
New Haven, Connecticut, 06519
About this study
The primary objective of this study is to determine whether sympathetic nervous system (SNS) activity in white adipose tissue (WAT) and brown adipose tissue (BAT), skeletal muscle and brain is altered in individuals with obesity in comparison to individuals with normal weight. Simultaneous multi-organ SNS activation will be obtained with a radiotracer for norepinephrine transporter (NET) for whole-body Positron Emission Tomography (PET) imaging and microneurography (peroneal muscle SNS activity).
The secondary objectives of this study are: 1) to evaluate whether gender differences affect peripheral SNS in healthy normal weight and obese men and women in adipose tissue (WAT and BAT) and muscle (resting/fasting); 2) To investigate the relationship between peripheral and central SNS activity in obesity, by correlating SNS activity in peripheral tissues (WAT, BAT, and muscle) and brain; and 3) To investigate NET CNS and peripheral SNS activity before and after a high carbohydrate mixed meal in lean and obese men and women.
- Being tested
- PET Scan, Mixed Meal Test, Muscle sympathetic nerve activity (MSNA), Oral Glucose Tolerance Test, Body Composition, Percent Body Fat & Percent Body Water (Tanita scale)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanDiagnostic test
Participants will come to the PET Center to undergo the whole body [11C]MRB PET scan. An intravenous bolus dose of MRB (~20mCi) will be injected by an infusion pump. PET data will be acquired dynamically for 120 min using the Siemens mCT-X whole-body PET/CT scanner using continuous bed motion to image multiple PET bed acquisitions from the top of the head to the lower abdominal region.
Mixed Meal TestDietary supplement
High Carbohydrate Mixed Meal Test (MMT): participants will be studied after a 10-hour overnight fast. A nurse will insert an intravenous (IV) catheter and subjects will ingest a liquid meal (65% carbohydrate, 20% fat, and 15% protein, corresponding to 40% of daily energy expenditure, in ~16 ounces) to be prepared by the Hospital Research Unit Metabolic Kitchen. Blood samples will be collected at -10, 0, 15, 30, 60, 90, and 120 min) for measurement of glucose, insulin and C-peptide concentrations. Plasma samples will be drawn at baseline and throughout the MMT for measurement of additional hormones (such as thyroid hormones, and catecholamines) and free fatty acids (FFA) levels.
Muscle sympathetic nerve activity (MSNA)Diagnostic test
Recording of multiunit postganglionic muscle sympathetic nerve activity (MSNA) will be made from the common peroneal nerve as it winds around the fibular head with the subject in the supine position with the subject's thigh comfortably supported. This procedure requires to first trace the course of the nerve using small electrical stimuli applied to the surface of the skin over the nerve or use of ultrasound to visually assist.
Oral Glucose Tolerance TestDiagnostic test
Following a 10-hour overnight fast, a nurse will insert an intravenous (IV) catheter. Subsequently, subjects will ingest 7.5 oz of Glucola, which contains 75 g of dextrose in orange flavored water. Blood samples will be taken at -15, 0, 10, 20, 30, 60, 90 and 120 minutes (after glucola ingestion) for the measurement of plasma glucose, insulin, and C-peptide concentrations, and calculation of measurements of insulin sensitivity index (Matsuda Index). Approximately 40 mL of blood will be drawn at this visit.
Body Composition, Percent Body Fat & Percent Body Water (Tanita scale)Other
will be assessed using bioelectrical impedance analysis Tanita® scale; which is a special multi frequency segmental body composition analyzer that delivers a very mild electrical current that allows measurement of fat mass, percent body fat, fat free mass, total body water, and percent body water. This test will be performed at screening visit.
CT ScanDiagnostic test
A CT scan will be performed for attenuation correction and to help delineate the BAT and other regions of interest (ROIs). Images will be reconstructed with an ordered subset expectation maximization algorithm using point spread function correction and time-of-flight information. To delineate fat (WAT, BAT) and skeletal muscle regions of interests (ROIs), CT images are first resliced to match the resolution and location of PET images. As performed in previous studies 2, a supraclavicular ROI is first manually drawn on the CT images. Within that area, the fat ROI is segmented using the CT images and an intensity window from -200 to -50 HU. Subsequently the fat ROI is segmented into WAT and BAT ROIs by using the 11C-MRB PET images: Standardized Uptake Value (SUV) ≥ 1.25 for BAT, SUV < 1.25 for WAT.
Body Composition, Percent Body Fat & Percent Body Water (DXA Scan)Other
For better accuracy, measurement of percent fat and percent body water will be obtained with whole body Dual X-Ray Absorptiometry (DXA) scan (Hologic®) on screening-OGTT visit. The scanner arm will move over the participant's body from feet to head. The machine uses a small amount of radiation (one tenth of the amount of radiation from a chest x-ray) to measure body fat, muscle and bone density.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with normal BMI | Active comparator | (BMI 18-25 kg/m2) Receives: Diagnostic Test: PET Scan; Dietary Supplement: Mixed Meal Test; Diagnostic Test: Muscle sympathetic nerve activity (MSNA); Diagnostic Test: Oral Glucose Tolerance Test; Other: Body Composition, Percent Body Fat & Percent Body Water (Tanita scale); Diagnostic Test: CT Scan; Other: Body Composition, Percent Body Fat & Percent Body Water (DXA Scan) |
| Individuals with obesity | Active comparator | (BMI 30-40 kg/m2) Receives: Diagnostic Test: PET Scan; Dietary Supplement: Mixed Meal Test; Diagnostic Test: Muscle sympathetic nerve activity (MSNA); Diagnostic Test: Oral Glucose Tolerance Test; Other: Body Composition, Percent Body Fat & Percent Body Water (Tanita scale); Diagnostic Test: CT Scan; Other: Body Composition, Percent Body Fat & Percent Body Water (DXA Scan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System
Lean individuals with a BMI of 18-25 and obese individuals with a BMI of 30-40 will undergo a PET/CT scan to determine group differences in sympathetic nervous system (SNS) activity in white adipose tissue (WAT), brown adipose tissue (BAT), and deltoid muscle. SNS activity will be determined by using [11C]MRB a radiotracer for PET imaging.
Measured: 120 minutes
Microneurography (Muscle Sympathetic Nerve Activity (MSNA)) Measured by Burst Frequency
Muscle sympathetic nerve activity will be quantified by identification and measurement of sympathetic bursts in the integrated neurogram and expressed as burst frequency (mean number of bursts per unit time) to determinate group differences in peroneal MSNA at baseline (fasting) and during MMT.
Measured: 30-60 minutes
Secondary outcomes (10)
DVR of Norepinephrine Transporter (NET) in the Central Nervous System (CNS)
Regional quantification of [11C]MRB uptake as distribution volume ratio (DVR ) will be used to measure NET in the CNS.
Measured: 120 minutes
DVR of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System After Mixed Meal Test
Measurement of peripheral SNS Activity with [11C]MRC for PET/CT before (fasting) and after a high carbohydrate mixed meal in individuals with normal weight and obesity.
Measured: 120 minutes
Plasma Glucose
Measurement of plasma glucose levels will be obtained at fasting and during the Mixed Meal Test (MMT). The normal range for glucose levels is 70-100 mg/dL.
Measured: 2 hours
Insulin Levels
Measurement of plasma insulin levels will be obtained at fasting and during the MMT. Insulin levels in the plasma are higher in individuals with obesity. The normal range for insulin is: < or = 19.6 mcg/dL
Measured: 2 hours
C-Peptide
Plasma samples will be drawn at baseline and throughout the MMT for measurement of C-Peptide. The normal range for C-Peptide is 0.80 - 3.85 ng/mL
Measured: 2 hours
Plasma Catecholamines (Epinephrine and Norepinephrine)
Measurement of epinephrine and norepinephrine levels in the plasma at fasting and during the MMT. The normal range for epinephrine is 0 to 140 pg/mL (764.3 pmol/L). The normal range for norepinephrine is 70 to 1700 pg/mL (413.8 to 10048.7 pmol/L).
Measured: 2 hours
Plasma Free Fatty Acids (FFA)
Percent of plasma free fatty acids levels will be obtained at fasting and during the Mixed Meal Test (MMT). FFA levels in the plasma are higher in individuals with obesity than individuals with normal weight.
Measured: 2 hours
Thyroid Function Tests
Plasma samples will be drawn at baseline and throughout the mixed meal test (MMT) for measurement of Thyroid Stimulating Hormone (TSH), free T4 (FT4) and total T3 (TT3). The normal range for TSH is : 0.4-4.5 mlU/L, FT4: 0.8-1.8 ng/dL, TT3: 76 - 181 ng/dL.
Measured: 2 hours
Electrocardiogram (EKG)- Heart Rate
EKG surface electrodes will be applied to the chest for measurement of heart rate and heart rate variability (QT Interval).
Measured: 30-60 minutes
Electrocardiogram (EKG) - RR Interval
EKG surface electrodes will be applied to the chest for measurement of RR interval.
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start23 Nov 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946552
- Sponsor's protocol ID
- 2000030749
- Other IDs
- 1R56DK129344-01
- Status last verified
- Feb 2024
- First submitted
- 15 Jun 2021
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Activation in Obesity
- ClinicalTrials.gov ID
- NCT04946552
- Acronym / sponsor ID
- 2000030749
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether sympathetic nervous system (SNS) activity in white adipose tissue (WAT) and brown adipose tissue (BAT), skeletal muscle and brain is altered in individuals with obesity in comparison to individuals with normal weight. Simultaneous multi-organ SNS activation will be obtained with a radiotracer for norepinephrine transporter (NET) for whole-body Positron Emission Tomography (PET) imaging and microneurography (peroneal muscle SNS activity).
The secondary objectives of this study are: 1) to evaluate whether gender differences affect peripheral SNS in healthy normal weight and obese men and women in adipose tissue (WAT and BAT) and muscle (resting/fasting); 2) To investigate the relationship between peripheral and central SNS activity in obesity, by correlating SNS activity in peripheral tissues (WAT, BAT, and muscle) and brain; and 3) To investigate NET CNS and peripheral SNS activity before and after a high carbohydrate mixed meal in lean and obese men and women.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with normal BMI | Active comparator | Diagnostic Test: PET Scan, Dietary Supplement: Mixed Meal Test, Diagnostic Test: Muscle sympathetic nerve activity (MSNA), Diagnostic Test: Oral Glucose Tolerance Test, Other: Body Composition, Percent Body Fat & Percent Body Water (Tanita scale), Diagnostic Test: CT Scan, Other: Body Composition, Percent Body Fat & Percent Body Water (DXA Scan)(BMI 18-25 kg/m2) |
| Individuals with obesity | Active comparator | Diagnostic Test: PET Scan, Dietary Supplement: Mixed Meal Test, Diagnostic Test: Muscle sympathetic nerve activity (MSNA), Diagnostic Test: Oral Glucose Tolerance Test, Other: Body Composition, Percent Body Fat & Percent Body Water (Tanita scale), Diagnostic Test: CT Scan, Other: Body Composition, Percent Body Fat & Percent Body Water (DXA Scan)(BMI 30-40 kg/m2) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Hypertension
- Cardiac or pulmonary disease,
- Known history of Type 1 or Type 2 diabetes
- Hepatic disease, swallowing and gastrointestinal disorders
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 |
|---|---|---|
| PET ScanParticipants will come to the PET Center to undergo the whole body [11C]MRB PET scan. An intravenous bolus dose of MRB (~20mCi) will be injected by an infusion pump. PET data will be acquired dynamically for 120 min using the Siemens mCT-X whole-body PET/CT scanner using continuous bed motion to image multiple PET bed acquisitions from the top of the head to the lower abdominal region. | Diagnostic test | Individuals with normal BMI, Individuals with obesity |
| Mixed Meal TestHigh Carbohydrate Mixed Meal Test (MMT): participants will be studied after a 10-hour overnight fast. A nurse will insert an intravenous (IV) catheter and subjects will ingest a liquid meal (65% carbohydrate, 20% fat, and 15% protein, corresponding to 40% of daily energy expenditure, in ~16 ounces) to be prepared by the Hospital Research Unit Metabolic Kitchen. Blood samples will be collected at -10, 0, 15, 30, 60, 90, and 120 min) for measurement of glucose, insulin and C-peptide concentrations. Plasma samples will be drawn at baseline and throughout the MMT for measurement of additional hormones (such as thyroid hormones, and catecholamines) and free fatty acids (FFA) levels. | Dietary supplement | Individuals with normal BMI, Individuals with obesity |
| Muscle sympathetic nerve activity (MSNA)Recording of multiunit postganglionic muscle sympathetic nerve activity (MSNA) will be made from the common peroneal nerve as it winds around the fibular head with the subject in the supine position with the subject's thigh comfortably supported. This procedure requires to first trace the course of the nerve using small electrical stimuli applied to the surface of the skin over the nerve or use of ultrasound to visually assist. | Diagnostic test | Individuals with normal BMI, Individuals with obesity |
| Oral Glucose Tolerance TestFollowing a 10-hour overnight fast, a nurse will insert an intravenous (IV) catheter. Subsequently, subjects will ingest 7.5 oz of Glucola, which contains 75 g of dextrose in orange flavored water. Blood samples will be taken at -15, 0, 10, 20, 30, 60, 90 and 120 minutes (after glucola ingestion) for the measurement of plasma glucose, insulin, and C-peptide concentrations, and calculation of measurements of insulin sensitivity index (Matsuda Index). Approximately 40 mL of blood will be drawn at this visit. | Diagnostic test | Individuals with normal BMI, Individuals with obesity |
| Body Composition, Percent Body Fat & Percent Body Water (Tanita scale)will be assessed using bioelectrical impedance analysis Tanita® scale; which is a special multi frequency segmental body composition analyzer that delivers a very mild electrical current that allows measurement of fat mass, percent body fat, fat free mass, total body water, and percent body water. This test will be performed at screening visit. | Other | Individuals with normal BMI, Individuals with obesity |
| CT ScanA CT scan will be performed for attenuation correction and to help delineate the BAT and other regions of interest (ROIs). Images will be reconstructed with an ordered subset expectation maximization algorithm using point spread function correction and time-of-flight information. To delineate fat (WAT, BAT) and skeletal muscle regions of interests (ROIs), CT images are first resliced to match the resolution and location of PET images. As performed in previous studies 2, a supraclavicular ROI is first manually drawn on the CT images. Within that area, the fat ROI is segmented using the CT images and an intensity window from -200 to -50 HU. Subsequently the fat ROI is segmented into WAT and BAT ROIs by using the 11C-MRB PET images: Standardized Uptake Value (SUV) ≥ 1.25 for BAT, SUV < 1.25 for WAT. | Diagnostic test | Individuals with normal BMI, Individuals with obesity |
| Body Composition, Percent Body Fat & Percent Body Water (DXA Scan)For better accuracy, measurement of percent fat and percent body water will be obtained with whole body Dual X-Ray Absorptiometry (DXA) scan (Hologic®) on screening-OGTT visit. The scanner arm will move over the participant's body from feet to head. The machine uses a small amount of radiation (one tenth of the amount of radiation from a chest x-ray) to measure body fat, muscle and bone density. | Other | Individuals with normal BMI, Individuals with obesity |
Primary outcome
Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System
Time frame: 120 minutes
Lean individuals with a BMI of 18-25 and obese individuals with a BMI of 30-40 will undergo a PET/CT scan to determine group differences in sympathetic nervous system (SNS) activity in white adipose tissue (WAT), brown adipose tissue (BAT), and deltoid muscle. SNS activity will be determined by using [11C]MRB a radiotracer for PET imaging.
Microneurography (Muscle Sympathetic Nerve Activity (MSNA)) Measured by Burst Frequency
Time frame: 30-60 minutes
Muscle sympathetic nerve activity will be quantified by identification and measurement of sympathetic bursts in the integrated neurogram and expressed as burst frequency (mean number of bursts per unit time) to determinate group differences in peroneal MSNA at baseline (fasting) and during MMT.
10 secondary outcomes
DVR of Norepinephrine Transporter (NET) in the Central Nervous System (CNS)
Time frame: 120 minutes
DVR of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System After Mixed Meal Test
Time frame: 120 minutes
Plasma Glucose
Time frame: 2 hours
Insulin Levels
Time frame: 2 hours
C-Peptide
Time frame: 2 hours
Plasma Catecholamines (Epinephrine and Norepinephrine)
Time frame: 2 hours
Plasma Free Fatty Acids (FFA)
Time frame: 2 hours
Thyroid Function Tests
Time frame: 2 hours
Electrocardiogram (EKG)- Heart Rate
Time frame: 30-60 minutes
Electrocardiogram (EKG) - RR Interval
Time frame: 30-60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET Scan, Mixed Meal Test and Muscle sympathetic nerve activity (MSNA) in people with Obesity and Healthy, run by Yale University 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 0 inclusion and 15 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 16 Feb 2024. 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 9 Nov 2023). 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?
Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System (time frame: 120 minutes). 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?
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 16 Feb 2024.