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Trial record 30 of 31 for:    Metreleptin

In Vivo Leptin Signaling in Humans After Acute Leptin Administration

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ClinicalTrials.gov Identifier: NCT01275053
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : August 3, 2017
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lean
Obese
Obese Diabetics
Intervention Drug: leptin
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Leptin
Hide Arm/Group Description leptin: 0.01mg/kg
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Leptin
Hide Arm/Group Description leptin: 0.01mg/kg
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
All participants Number Analyzed 12 participants
43.3  (10.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
1.Primary Outcome
Title Leptin Signaling
Hide Description

Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration.

The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration.

The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration.

Time Frame Baseline and 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects received biopsies before and 30 min after leptin administration.
Arm/Group Title Leptin
Hide Arm/Group Description:
leptin: 0.01mg/kg
Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: fold change
3.1
(2.8 to 3.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leptin
Hide Arm/Group Description leptin: 0.01mg/kg
All-Cause Mortality
Leptin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Leptin
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Leptin
Affected / at Risk (%)
Total   0/12 (0.00%) 
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: Dr. Christos Mantzoros
Organization: Beth Israel Deaconess Medical Center
Phone: 6176678633
Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01275053     History of Changes
Other Study ID Numbers: 2002P000097
First Submitted: January 10, 2011
First Posted: January 12, 2011
Results First Submitted: January 6, 2017
Results First Posted: August 3, 2017
Last Update Posted: October 17, 2017