Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2008-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Obese will complete baseline outcome measurements then the VLCD intervention with post outcome measurements .
OTHER
NONE
Study Groups
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Lean controls
Lean complete baseline outcome measures only
PET scan
Both lean and obese undergo a PET scan of the brain using the radioligand,fallypride \[18F\] at baseline. Obese subjects who complete caloric restriction will have repeat scan after diet.
Completed at baseline and post-VLCD
Oral glucose tolerance test
Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period Completed at baseline by both lean and obese and in obese post-VLCD
MRI
An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese
Psychological scales to assess attitudes and behaviors related to eating and quality of life
A series of short psychological scales will be administered during the study. Completed at baseline
Obese
Obese completing baseline and post-VLCD outcome measures
PET scan
Both lean and obese undergo a PET scan of the brain using the radioligand,fallypride \[18F\] at baseline. Obese subjects who complete caloric restriction will have repeat scan after diet.
Completed at baseline and post-VLCD
Oral glucose tolerance test
Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period Completed at baseline by both lean and obese and in obese post-VLCD
MRI
An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese
Psychological scales to assess attitudes and behaviors related to eating and quality of life
A series of short psychological scales will be administered during the study. Completed at baseline
Caloric Restriction
Obese participants only complete a short-term (\~10days) very low calorie diet
Interventions
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PET scan
Both lean and obese undergo a PET scan of the brain using the radioligand,fallypride \[18F\] at baseline. Obese subjects who complete caloric restriction will have repeat scan after diet.
Completed at baseline and post-VLCD
Oral glucose tolerance test
Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period Completed at baseline by both lean and obese and in obese post-VLCD
MRI
An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese
Psychological scales to assess attitudes and behaviors related to eating and quality of life
A series of short psychological scales will be administered during the study. Completed at baseline
Caloric Restriction
Obese participants only complete a short-term (\~10days) very low calorie diet
Eligibility Criteria
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Inclusion Criteria
* obese BMI \> 30kg/m2 and Weight less than 350 lbs
* lean control BMI 18-25kg/m2
Exclusion Criteria
* History of Substance Abuse, including but exclusive to alcohol, cocaine, marijuana, heroin, nicotine
* Current psychiatric disorder or significant h/o disorder
* Use or any antidepressants or antipsychotics for last 3-6months or depot antipsychotics in the last 12 months
* Any condition felt by PI or co-investigators to interfere with ability to complete the study
* Inability to abstain from alcohol, physical exercise or \> 1 cup of coffee or equivalent daily for 3 days prior to imaging studies
* Significant co-morbidities including atherosclerotic disease, metabolic disease, liver or renal insufficiency or abnormality found on MRI
* Any condition which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning
* Subjects on medications determined by PI, ex. sibutramine, frequent benzodiazepines or related drugs, which could affect quality of study for last 3 months.
18 Years
60 Years
ALL
Yes
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Julia P.Dunn,MD
Physician
Principal Investigators
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Julia P Dunn, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Robert M Kessler, MD
Role: STUDY_DIRECTOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Dunn JP, Abumrad NN, Patterson BW, Kessler RM, Tamboli RA. Brief communication: beta-cell function influences dopamine receptor availability. PLoS One. 2019 Mar 8;14(3):e0212738. doi: 10.1371/journal.pone.0212738. eCollection 2019.
Dunn JP, Abumrad NN, Kessler RM, Patterson BW, Li R, Marks-Shulman P, Tamboli RA. Caloric Restriction-Induced Decreases in Dopamine Receptor Availability are Associated with Leptin Concentration. Obesity (Silver Spring). 2017 Nov;25(11):1910-1915. doi: 10.1002/oby.22023. Epub 2017 Sep 25.
Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
Dunn JP, Kessler RM, Feurer ID, Volkow ND, Patterson BW, Ansari MS, Li R, Marks-Shulman P, Abumrad NN. Relationship of dopamine type 2 receptor binding potential with fasting neuroendocrine hormones and insulin sensitivity in human obesity. Diabetes Care. 2012 May;35(5):1105-11. doi: 10.2337/dc11-2250. Epub 2012 Mar 19.
Other Identifiers
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IRB#080861 and 061246
Identifier Type: -
Identifier Source: org_study_id
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