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=99 Participants
|
29.1 years
n=107 Participants
|
48.6 years
n=206 Participants
|
27.6 years
n=7 Participants
|
35.2 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=31 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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels
|
7147 pM*min
Standard Deviation 3547
|
11725 pM*min
Standard Deviation 4799
|
11898 pM*min
Standard Deviation 9996
|
28060 pM*min
Standard Deviation 8414
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels
|
12894 pM*min/ml
Standard Deviation 8803
|
11830 pM*min/ml
Standard Deviation 4516
|
19386 pM*min/ml
Standard Deviation 16823
|
60559 pM*min/ml
Standard Deviation 36610
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Ghrelin Levels
|
172886 pg*min/ml
Standard Deviation 89970
|
129451 pg*min/ml
Standard Deviation 46926
|
207863 pg*min/ml
Standard Deviation 111684
|
166195 pg*min/ml
Standard Deviation 110140
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels
|
90016 pg*min/ml
Standard Deviation 25755
|
65131 pg*min/ml
Standard Deviation 14914
|
82474 pg*min/ml
Standard Deviation 21072
|
144702 pg*min/ml
Standard Deviation 27466
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Glucose Levels
|
30683 mg*min/dl
Standard Deviation 1249
|
28735 mg*min/dl
Standard Deviation 1269
|
32566 mg*min/dl
Standard Deviation 1531
|
31364 mg*min/dl
Standard Deviation 869
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Insulin Levels
|
1765 mU*min/ml
Standard Deviation 1555
|
2072 mU*min/ml
Standard Deviation 970
|
2103 mU*min/ml
Standard Deviation 1645
|
3021 mU*min/ml
Standard Deviation 1426
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Leptin Levels
|
2050 ng*min/ml
Standard Deviation 2233
|
3639 ng*min/ml
Standard Deviation 4470
|
5439 ng*min/ml
Standard Deviation 4671
|
4973 ng*min/ml
Standard Deviation 5313
|
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 |
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
|
|---|---|---|---|---|
|
Change in Circulating Adiponectin Levels
|
1546442 ng*min/ml
Standard Deviation 500930
|
2273306 ng*min/ml
Standard Deviation 1068651
|
1778846 ng*min/ml
Standard Deviation 857433
|
1970601 ng*min/ml
Standard Deviation 961699
|
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