Trial Outcomes & Findings for Effect of Increased Free Fatty Acids on Leptin Function (NCT NCT01520454)
NCT ID: NCT01520454
Last Updated: 2018-05-11
Results Overview
The GLP-1 area under the curve (AUC) was calculated from baseline to six hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline to 6 hours
Results posted on
2018-05-11
Participant Flow
Participant milestones
| Measure |
Placebo
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours
|
High Dose Fat Solution
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Low Dose Fat Solution
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Oral Fat
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
5
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Increased Free Fatty Acids on Leptin Function
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
35.3 years
n=5 Participants
|
29.1 years
n=7 Participants
|
48.6 years
n=5 Participants
|
27.6 years
n=4 Participants
|
35.2 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas under the curve are presented
The GLP-1 area under the curve (AUC) was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels
|
28060 pM*min
Standard Deviation 8414
|
11898 pM*min
Standard Deviation 9996
|
7147 pM*min
Standard Deviation 3547
|
11725 pM*min
Standard Deviation 4799
|
PRIMARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas under the curve are presented
The GIP AUC fwas calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels
|
60559 pM*min/ml
Standard Deviation 36610
|
19386 pM*min/ml
Standard Deviation 16823
|
12894 pM*min/ml
Standard Deviation 8803
|
11830 pM*min/ml
Standard Deviation 4516
|
PRIMARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas under the curve are presented
The Ghrelin AUC was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Ghrelin Levels
|
166195 pg*min/ml
Standard Deviation 110140
|
207863 pg*min/ml
Standard Deviation 111684
|
172886 pg*min/ml
Standard Deviation 89970
|
129451 pg*min/ml
Standard Deviation 46926
|
PRIMARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas under the curve are presented
The PYY AUC was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels
|
144702 pg*min/ml
Standard Deviation 27466
|
82474 pg*min/ml
Standard Deviation 21072
|
90016 pg*min/ml
Standard Deviation 25755
|
65131 pg*min/ml
Standard Deviation 14914
|
SECONDARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas Under the Curve are presented
The Glucose AUC was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Glucose Levels
|
31364 mg*min/dl
Standard Deviation 869
|
32566 mg*min/dl
Standard Deviation 1531
|
30683 mg*min/dl
Standard Deviation 1249
|
28735 mg*min/dl
Standard Deviation 1269
|
SECONDARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas Under the Curve are presented
The Insulin AUC was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Insulin Levels
|
3021 mU*min/ml
Standard Deviation 1426
|
2103 mU*min/ml
Standard Deviation 1645
|
1765 mU*min/ml
Standard Deviation 1555
|
2072 mU*min/ml
Standard Deviation 970
|
SECONDARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas Under the Curve are presented
The Leptin AUC was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Leptin Levels
|
4973 ng*min/ml
Standard Deviation 5313
|
5439 ng*min/ml
Standard Deviation 4671
|
2050 ng*min/ml
Standard Deviation 2233
|
3639 ng*min/ml
Standard Deviation 4470
|
SECONDARY outcome
Timeframe: Baseline to 6 hoursPopulation: Areas Under the Curve are presented
The Adiponectin AUC was calculated from baseline to six hours
Outcome measures
| Measure |
Oral Fat
n=6 Participants
Oral fat load with IV saline
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses
|
Low Dose Fat Solution
n=5 Participants
Low dose IV Intralipid with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
Placebo
n=9 Participants
IV saline with heparin, oral water
Saline: IV saline at 0.83 mL/kg/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
High Dose Fat Solution
n=6 Participants
Intralipid at high dose, with heparin and PO water
Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Water: Water by mouth
Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours
|
|---|---|---|---|---|
|
Change in Circulating Adiponectin Levels
|
1970601 ng*min/ml
Standard Deviation 961699
|
1778846 ng*min/ml
Standard Deviation 857433
|
1546442 ng*min/ml
Standard Deviation 500930
|
2273306 ng*min/ml
Standard Deviation 1068651
|
SECONDARY outcome
Timeframe: Baseline to 6 hoursPopulation: The analysis unfortunately can not be performed due to technical reasons as STAT3 was not able to be measured in the samples/not enough volume was left to perform the appropriate tests after trouble-shooting.
Intracellular signaling mechanisms downstream of leptin (particularly the STAT3 pathway) in response to lipid administration as represented by phosphorylation (pSTAT3).
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Fat Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose Fat Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Fat
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
Dr. Christos Manztoros
Beth Israel Deaconess Medical Center
Phone: 617-667-8630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place