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Role of Leptin in the Neuroendocrine and Immune Response to Fasting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140231
First Posted: September 1, 2005
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: December 29, 2015  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)


Participant Flow for 5 periods

Period 1:   Fed State 1 Day- day5
    Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo   Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
STARTED   7   6 
COMPLETED   7   6 
NOT COMPLETED   0   0 

Period 2:   Washout 8weeks
    Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo   Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
STARTED   7   6 
COMPLETED   7   6 
NOT COMPLETED   0   0 

Period 3:   First Fasting State 3 Days With Placebo
    Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo   Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
STARTED   7   6 
COMPLETED   7   6 
NOT COMPLETED   0   0 

Period 4:   Washout 8 Weeks
    Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo   Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
STARTED   7   6 
COMPLETED   7   6 
NOT COMPLETED   0   0 

Period 5:   Fasting State With Leptin and Crossover
    Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo   Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met
STARTED   7   6 
COMPLETED   7   6 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo

r-metHuLeptin self-administered subcutaneously

r-metHuLeptin: recombinant human leptin

Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin

Placebo, administered in same method as active arm.

placebo: placebo (no active drug)

Total Total of all reporting groups

Baseline Measures
   Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo   Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   13 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 26  (5)   25  (5)   25.5  (0.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7 100.0%      6 100.0%      13 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   7   6   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cortisol   [ Time Frame: four days ]

2.  Primary:   ACTH Mean Level   [ Time Frame: 4 days ]

3.  Primary:   Immune Function CD3 Count   [ Time Frame: 4 days ]

4.  Secondary:   %Fat Mass   [ Time Frame: four days ]

5.  Secondary:   (RMR)   [ Time Frame: four days ]

6.  Secondary:   Autonomic Function   [ Time Frame: four days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study is confined to lean, healthy female subjects; therefore, our results should not be generalized to male, obese,or diabetic subjects


  More Information
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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
e-mail: cmantzor@bidmc.harvard.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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