N/A
N=5
Sympathetic Activation in Obesity
Obesity · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04946552 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System — 0.13; -0.025; 0.095; -0.03 DVR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PET Scan (Diagnostic_test); Mixed Meal Test (Dietary_supplement); Muscle sympathetic nerve activity (MSNA) (Diagnostic_test); Oral Glucose Tolerance Test (Diagnostic_test); Body Composition, Percent Body Fat & Percent Body Water (Tanita scale) (Other); CT Scan (Diagnostic_test); Body Composition, Percent Body Fat & Percent Body Water (DXA Scan) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System |
0.13; -0.025; 0.095; -0.03; -0.095; -0.195 | — |
| PRIMARY Microneurography (Muscle Sympathetic Nerve Activity (MSNA)) Measured by Burst Frequency |
11.18; 9.541; 15.63; 11.60 | — |
| SECONDARY DVR of Norepinephrine Transporter (NET) in the Central Nervous System (CNS) |
0.549; 0.525 | — |
| SECONDARY DVR of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System After Mixed Meal Test |
0.577; 0.491; 0.521; 0.559 | — |
| SECONDARY Plasma Glucose |
— | — |
| SECONDARY Insulin Levels |
7.07; 15.55; 61.06; 78.37 | — |
| SECONDARY C-Peptide |
— | — |
| SECONDARY Plasma Catecholamines (Epinephrine and Norepinephrine) |
0.0487; 0.0131; 0.0155; 0.0136; 0.146; 0.135 | — |
| SECONDARY Plasma Free Fatty Acids (FFA) |
380; 412; 419; 404 | — |
| SECONDARY Thyroid Function Tests |
— | — |
| SECONDARY Electrocardiogram (EKG)- Heart Rate |
61.8; 74.2; 65.6; 71.7 | — |
| SECONDARY Electrocardiogram (EKG) - RR Interval |
0.94; 1.01; 0.91; 0.85 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria:In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18-45 years
- In good general health as evidenced by medical history and lean (BMI 18.5-24.9 kg/m2) or non-diabetic obese (BMI 30-50 kg/m2) with a fasting plasma glucose (FPG) <100 mg/dL and a hemoglobin A1c <5.7%.
Exclusion Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT04946552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.