Trial Outcomes & Findings for Dopamine and Insulin Resistance (NCT NCT00802204)
NCT ID: NCT00802204
Last Updated: 2017-05-10
Results Overview
Region of interest compared to reference region to calculate binding potential
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline and after 8-10days VLCD
Results posted on
2017-05-10
Participant Flow
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
Participant milestones
| Measure |
Lean
BMI\<\~25kg/m2
|
Obese
BMI\>/=30kg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
19
|
|
Overall Study
COMPLETED
|
8
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dopamine and Insulin Resistance
Baseline characteristics by cohort
| Measure |
Lean
n=8 Participants
|
Obese
n=18 Participants
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 9 • n=93 Participants
|
39 years
STANDARD_DEVIATION 8 • n=4 Participants
|
39 years
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American Participants
|
1 participants
n=93 Participants
|
7 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian Participants
|
7 participants
n=93 Participants
|
11 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
18 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Weight
|
60 kg
STANDARD_DEVIATION 7 • n=93 Participants
|
104 kg
STANDARD_DEVIATION 17 • n=4 Participants
|
91 kg
STANDARD_DEVIATION 26 • n=27 Participants
|
|
BMI
|
23 kg/m2
STANDARD_DEVIATION 2 • n=93 Participants
|
39 kg/m2
STANDARD_DEVIATION 6 • n=4 Participants
|
33 kg/m2
STANDARD_DEVIATION 9 • n=27 Participants
|
|
Beck Depression Inventory II(BDI-II)
|
3 scores on a scale
STANDARD_DEVIATION 5 • n=93 Participants
|
7 scores on a scale
STANDARD_DEVIATION 6 • n=4 Participants
|
6 scores on a scale
STANDARD_DEVIATION 6 • n=27 Participants
|
|
OGTT_SI (Insulin Sensitivity from OGTT)
|
11.2 (10-4min-1/µU*mL)
STANDARD_DEVIATION 4.1 • n=93 Participants
|
3.98 (10-4min-1/µU*mL)
STANDARD_DEVIATION 2.7 • n=4 Participants
|
6 (10-4min-1/µU*mL)
STANDARD_DEVIATION 5 • n=27 Participants
|
|
Insulin
|
6 (µU/ml)
STANDARD_DEVIATION 2 • n=93 Participants
|
18 (µU/ml)
STANDARD_DEVIATION 9 • n=4 Participants
|
14 (µU/ml)
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Glucose
|
82 mg/dl
STANDARD_DEVIATION 6 • n=93 Participants
|
87 mg/dl
STANDARD_DEVIATION 9 • n=4 Participants
|
86 mg/dl
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Leptin
|
13 ng/ml
STANDARD_DEVIATION 5 • n=93 Participants
|
43 ng/ml
STANDARD_DEVIATION 12 • n=4 Participants
|
34 ng/ml
STANDARD_DEVIATION 18 • n=27 Participants
|
|
Acyl Ghrelin
|
235 pg/ml
STANDARD_DEVIATION 104 • n=93 Participants
|
78 pg/ml
STANDARD_DEVIATION 55 • n=4 Participants
|
132 pg/ml
STANDARD_DEVIATION 106 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 8-10days VLCDPopulation: Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD
Region of interest compared to reference region to calculate binding potential
Outcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
n=15 Participants
|
|---|---|---|---|
|
Striatal DRD2 Receptor Binding
caudate
|
28 ratio
Standard Deviation 3
|
33 ratio
Standard Deviation 3
|
32 ratio
Standard Deviation 3
|
|
Striatal DRD2 Receptor Binding
putamen
|
33 ratio
Standard Deviation 3
|
38 ratio
Standard Deviation 3
|
36 ratio
Standard Deviation 4
|
|
Striatal DRD2 Receptor Binding
ventral striatum
|
19 ratio
Standard Deviation 4
|
22 ratio
Standard Deviation 3
|
22 ratio
Standard Deviation 3
|
PRIMARY outcome
Timeframe: Baseline to post 8-10days after VLCDmicroU/ml
Outcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
n=15 Participants
|
|---|---|---|---|
|
Insulin
|
6 microU/ml
Standard Deviation 2
|
19 microU/ml
Standard Deviation 10
|
11 microU/ml
Standard Deviation 5
|
PRIMARY outcome
Timeframe: Baseline to post 8-10days after VLCDOutcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
n=15 Participants
|
|---|---|---|---|
|
Glucose
|
82 mg/dL
Standard Deviation 6
|
87 mg/dL
Standard Deviation 9
|
81 mg/dL
Standard Deviation 7
|
PRIMARY outcome
Timeframe: Baseline to post 8-10days after VLCDOutcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
n=15 Participants
|
|---|---|---|---|
|
Leptin
|
13 ng/ml
Standard Deviation 5
|
43 ng/ml
Standard Deviation 12
|
34 ng/ml
Standard Deviation 15
|
PRIMARY outcome
Timeframe: Baseline to post 8-10days after VLCDOutcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
n=15 Participants
|
|---|---|---|---|
|
Acyl Ghrelin
|
235 pg/ml
Standard Deviation 104
|
78 pg/ml
Standard Deviation 55
|
59 pg/ml
Standard Deviation 36
|
PRIMARY outcome
Timeframe: Baseline to post 8-10days after VLCDPopulation: 9 lean enroll but only 8 complete. A ll lean complete study after baseline outcome measurements. 19 obese enroll but only 18 complete baseline studies and of these 15 completed the VLCD
Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method
Outcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
n=15 Participants
|
|---|---|---|---|
|
Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)
|
11 10-4*min-1*microU-1*mL
Standard Deviation 4
|
4 10-4*min-1*microU-1*mL
Standard Deviation 3
|
4 10-4*min-1*microU-1*mL
Standard Deviation 3
|
SECONDARY outcome
Timeframe: BaselineIncreased scores indicate increased binge eating behaviors. Score 0-46
Outcome measures
| Measure |
Lean Baseline
n=8 Participants
|
Obese Baseline
n=18 Participants
|
Obese Post-diet
|
|---|---|---|---|
|
Binge Eating Score Questionnaire
|
6 score from questionnaire
Standard Deviation 6
|
12 score from questionnaire
Standard Deviation 7
|
—
|
Adverse Events
Lean
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place