Trial Outcomes & Findings for Leptin in Human Energy and Neuroendocrine Homeostasis (NCT NCT00265980)
NCT ID: NCT00265980
Last Updated: 2019-09-18
Results Overview
To measure the metabolic changes associated with maintenance of a reduced body weight (in kcal/day)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline, 11 weeks, 18 weeks
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
Leptin Depletion Study Participants (Total)
Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
Weight Initial
|
22
|
|
Overall Study
Weight -10% Placebo
|
22
|
|
Overall Study
Weight -10% Leptin
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leptin in Human Energy and Neuroendocrine Homeostasis
Baseline characteristics by cohort
| Measure |
Leptin Depletion Study Participants (Total)
n=22 Participants
Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
|
|---|---|
|
Age, Customized
Age
|
34.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
|
Fa-free mass (FFM)
|
62.4 kg
STANDARD_DEVIATION 14.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 11 weeks, 18 weeksTo measure the metabolic changes associated with maintenance of a reduced body weight (in kcal/day)
Outcome measures
| Measure |
Leptin Depletion Study Participants (Total)
n=22 Participants
Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
|
|---|---|
|
Total Energy Expenditure (TEE)
Weight initial
|
3131 kcal/day
Standard Deviation 500
|
|
Total Energy Expenditure (TEE)
Weight -10% placebo
|
2457 kcal/day
Standard Deviation 410
|
|
Total Energy Expenditure (TEE)
Weight -10% leptin
|
2766 kcal/day
Standard Deviation 799
|
SECONDARY outcome
Timeframe: Baseline, 11 weeks, 18 weeksTo measure the total energy expenditure/fat-free mass (FFM) (in kcal/kg).
Outcome measures
| Measure |
Leptin Depletion Study Participants (Total)
n=22 Participants
Each of the 22 participant went through the stages (arms) of obtaining the initial weight (Weight Initial), reducing weight maintenance (placebo injection), and repletion of leptin (leptin injection).
|
|---|---|
|
TEE/FFM
Weight initial
|
51.1 kcal/kg
Standard Deviation 6.3
|
|
TEE/FFM
Weight -10% placebo
|
41.7 kcal/kg
Standard Deviation 6.2
|
|
TEE/FFM
Weight -10% leptin
|
48.1 kcal/kg
Standard Deviation 12.7
|
Adverse Events
Leptin Depletion Study Participants (Total)
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
Michael Rosenbaum, MD
Professor of Pediatrics and Medicine at the Columbia University
Phone: 212-305-9949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place