Trial Outcomes & Findings for Role of Leptin in the Neuroendocrine and Immune Response to Fasting (NCT NCT00140231)
NCT ID: NCT00140231
Last Updated: 2017-06-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
four days
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo
Six young, healthy, and lean women (age, 22.8,; BMI,21.7kg/m2) who were eumenor- rheic were enrolled in a clinical researchcenter- based, randomized, cross-over interventional study involving three separate 5-day-long inpatient admissions (22). Six subjects with a cross-over design, enabling paired comparisons, would provide 80% power to detect a difference of 1.4 SD between different conditionsat the conventional
a=0.05 level. In thefirst admission, the subjects were studied in the isocaloric fed state, whereas in the following two admissions the subjects were studied in the prolonged fasting state for 72 h and were randomized to receive either placebo or metreleptin at replacement doses. A cross-over to the opposite arm took place in the later admission so that all six subjects received both placebo and metreleptin.
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
Fed State 1 Day- day5
STARTED
|
7
|
6
|
|
Fed State 1 Day- day5
COMPLETED
|
7
|
6
|
|
Fed State 1 Day- day5
NOT COMPLETED
|
0
|
0
|
|
Washout 8weeks
STARTED
|
7
|
6
|
|
Washout 8weeks
COMPLETED
|
7
|
6
|
|
Washout 8weeks
NOT COMPLETED
|
0
|
0
|
|
First Fasting State 3 Days With Placebo
STARTED
|
7
|
6
|
|
First Fasting State 3 Days With Placebo
COMPLETED
|
7
|
6
|
|
First Fasting State 3 Days With Placebo
NOT COMPLETED
|
0
|
0
|
|
Washout 8 Weeks
STARTED
|
7
|
6
|
|
Washout 8 Weeks
COMPLETED
|
7
|
6
|
|
Washout 8 Weeks
NOT COMPLETED
|
0
|
0
|
|
Fasting State With Leptin and Crossover
STARTED
|
7
|
6
|
|
Fasting State With Leptin and Crossover
COMPLETED
|
7
|
6
|
|
Fasting State With Leptin and Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Leptin in the Neuroendocrine and Immune Response to Fasting
Baseline characteristics by cohort
| Measure |
Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo
n=7 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin
n=6 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 5 • n=99 Participants
|
25 years
STANDARD_DEVIATION 5 • n=107 Participants
|
25.5 years
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: four daysOutcome measures
| Measure |
Metreleptin
n=13 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Placebo
n=13 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
Cortisol
|
17.5 ug/dl
Standard Deviation 0.9
|
16.9 ug/dl
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 4 daysResponse of ACTH to leptin administration in fed and fasting state from baseline was measured
Outcome measures
| Measure |
Metreleptin
n=13 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Placebo
n=13 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
ACTH Mean Level
baseline fed
|
10.48 pg/ml
Standard Error 1.28
|
9.33 pg/ml
Standard Error 1.23
|
|
ACTH Mean Level
fasting
|
9.89 pg/ml
Standard Error 2.01
|
8.74 pg/ml
Standard Error 1.75
|
PRIMARY outcome
Timeframe: 4 daysOutcome measures
| Measure |
Metreleptin
n=13 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Placebo
n=13 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
Immune Function CD3 Count
|
302 cells/ul
Standard Error 185
|
838 cells/ul
Standard Error 268
|
SECONDARY outcome
Timeframe: four daysOutcome measures
| Measure |
Metreleptin
n=13 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Placebo
n=13 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
%Fat Mass
|
29.1 fat%
Standard Deviation 2.2
|
29.3 fat%
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: four daysResting Metabolic rate using calorimetry
Outcome measures
| Measure |
Metreleptin
n=13 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Placebo
n=13 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
(RMR)
|
1.344 kcal/d
Standard Deviation 34
|
1.352 kcal/d
Standard Deviation 43
|
SECONDARY outcome
Timeframe: four daysaldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1
Outcome measures
| Measure |
Metreleptin
n=13 Participants
r-metHuLeptin self-administered subcutaneously
r-metHuLeptin: recombinant human leptin
|
Placebo
n=13 Participants
Placebo, administered in same method as active arm.
placebo: placebo (no active drug)
|
|---|---|---|
|
Autonomic Function
Day 4
|
132 pg/ml
Standard Error 27.0
|
112 pg/ml
Standard Error 23.5
|
|
Autonomic Function
day 1 baseline
|
66.1 pg/ml
Standard Error 11.7
|
66.0 pg/ml
Standard Error 12.8
|
Adverse Events
Metreleptin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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