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Dopamine and Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00802204
First Posted: December 4, 2008
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julia P.Dunn,MD, Vanderbilt University
Results First Submitted: July 14, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Obesity
Interventions: Radiation: PET scan
Procedure: Oral glucose tolerance test
Procedure: MRI
Behavioral: Psychological scales to assess attitudes and behaviors related to eating and quality of life
Other: Caloric Restriction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

9 lean enroll but only 8 complete. The lean complete study after baseline outcome measurements.

19 obese enroll but only 18 complete baseline outcome measurements and of these 15 completed the VLCD and post-outcome measurements


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lean BMI<~25kg/m2
Obese BMI>/=30kg/m2

Participant Flow:   Overall Study
    Lean   Obese
STARTED   9   19 
COMPLETED   8   18 
NOT COMPLETED   1   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lean No text entered.
Obese No text entered.
Total Total of all reporting groups

Baseline Measures
   Lean   Obese   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   18   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (9)   39  (8)   39  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8 100.0%      18 100.0%      26 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American Participants   1   7   8 
Caucasian Participants   7   11   18 
Region of Enrollment 
[Units: Participants]
     
United States   8   18   26 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 60  (7)   104  (17)   91  (26) 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 23  (2)   39  (6)   33  (9) 
Beck Depression Inventory II(BDI-II) [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 3  (5)   7  (6)   6  (6) 
[1] 0-63 with higher scores indicating increased depressive symptoms. Scores above 20 indicate moderate depressive symptoms.
OGTT_SI (Insulin Sensitivity from OGTT) [1] 
[Units: (10-4min-1/µU*mL)]
Mean (Standard Deviation)
 11.2  (4.1)   3.98  (2.7)   6  (5) 
[1] Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the oral minimal model method
Insulin 
[Units: (µU/ml)]
Mean (Standard Deviation)
 6  (2)   18  (9)   14  (10) 
Glucose 
[Units: Mg/dl]
Mean (Standard Deviation)
 82  (6)   87  (9)   86  (8) 
Leptin 
[Units: Ng/ml]
Mean (Standard Deviation)
 13  (5)   43  (12)   34  (18) 
Acyl Ghrelin 
[Units: Pg/ml]
Mean (Standard Deviation)
 235  (104)   78  (55)   132  (106) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Striatal DRD2 Receptor Binding   [ Time Frame: Baseline and after 8-10days VLCD ]

2.  Primary:   Insulin   [ Time Frame: Baseline to post 8-10days after VLCD ]

3.  Primary:   Glucose   [ Time Frame: Baseline to post 8-10days after VLCD ]

4.  Primary:   Leptin   [ Time Frame: Baseline to post 8-10days after VLCD ]

5.  Primary:   Acyl Ghrelin   [ Time Frame: Baseline to post 8-10days after VLCD ]

6.  Primary:   Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)   [ Time Frame: Baseline to post 8-10days after VLCD ]

7.  Secondary:   Binge Eating Score Questionnaire   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julia Dunn, MD
Organization: Vanderbilt University
phone: 615-343-8389
e-mail: julia.dunn@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Julia P.Dunn,MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00802204     History of Changes
Other Study ID Numbers: IRB#080861 and 061246
First Submitted: December 2, 2008
First Posted: December 4, 2008
Results First Submitted: July 14, 2016
Results First Posted: May 10, 2017
Last Update Posted: May 10, 2017