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Trial record 14 of 31 for:    Metreleptin

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

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ClinicalTrials.gov Identifier: NCT00140231
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Amgen
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Fasting
Interventions Drug: r-metHuLeptin
Other: placebo
Enrollment 13

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
Hide Arm/Group Description

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

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Period Title: Fed State 1 Day- day5
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Washout 8weeks
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: First Fasting State 3 Days With Placebo
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Washout 8 Weeks
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Fasting State With Leptin and Crossover
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin Total
Hide Arm/Group Description

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
6
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
26  (5) 25  (5) 25.5  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
7
 100.0%
6
 100.0%
13
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 13 participants
7 6 13
1.Primary Outcome
Title Cortisol
Hide Description [Not Specified]
Time Frame four days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description:

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: ug/dl
17.5  (0.9) 16.9  (1.9)
2.Primary Outcome
Title ACTH Mean Level
Hide Description Response of ACTH to leptin administration in fed and fasting state from baseline was measured
Time Frame 4 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description:

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Overall Number of Participants Analyzed 13 13
Mean (Standard Error)
Unit of Measure: pg/ml
baseline fed 10.48  (1.28) 9.33  (1.23)
fasting 9.89  (2.01) 8.74  (1.75)
3.Primary Outcome
Title Immune Function CD3 Count
Hide Description [Not Specified]
Time Frame 4 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description:

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Overall Number of Participants Analyzed 13 13
Mean (Standard Error)
Unit of Measure: cells/ul
302  (185) 838  (268)
4.Secondary Outcome
Title %Fat Mass
Hide Description [Not Specified]
Time Frame four days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description:

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: fat%
29.1  (2.2) 29.3  (1.9)
5.Secondary Outcome
Title (RMR)
Hide Description Resting Metabolic rate using calorimetry
Time Frame four days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description:

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: kcal/d
1.344  (34) 1.352  (43)
6.Secondary Outcome
Title Autonomic Function
Hide Description aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1
Time Frame four days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description:

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Overall Number of Participants Analyzed 13 13
Mean (Standard Error)
Unit of Measure: pg/ml
Day 4 132  (27.0) 112  (23.5)
day 1 baseline 66.1  (11.7) 66.0  (12.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metreleptin Placebo
Hide Arm/Group Description

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

All-Cause Mortality
Metreleptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Metreleptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metreleptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Our study is confined to lean, healthy female subjects; therefore, our results should not be generalized to male, obese,or diabetic subjects
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christos Mantzoros
Organization: BIDMC
Phone: 6176678633
Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140231     History of Changes
Other Study ID Numbers: 2002P000049
2M01RR001032-30 ( U.S. NIH Grant/Contract )
5R01DK058785-07 ( U.S. NIH Grant/Contract )
First Submitted: August 30, 2005
First Posted: September 1, 2005
Results First Submitted: December 29, 2015
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017