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Effect of Increased Free Fatty Acids on Leptin Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01520454
First received: January 4, 2012
Last updated: March 16, 2017
Last verified: March 2017
Results First Received: December 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Basic Science
Conditions: Obesity
Leptin Resistance
Interventions: Drug: Saline
Drug: Intralipid
Dietary Supplement: Water
Dietary Supplement: oral fat
Drug: Heparin

  Participant Flow
  Hide Participant Flow

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
Placebo

IV saline with heparin, oral water

Saline: IV saline at 0.83 mL/kg/hr for six hours

Water: Water by mouth

Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours

High Dose Fat Solution

Intralipid at high dose, with heparin and PO water

Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours

Water: Water by mouth

Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours

Low Dose Fat Solution

Low dose IV Intralipid with heparin and PO water

Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours

Water: Water by mouth

Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours

Oral Fat

Oral fat load with IV saline

Saline: IV saline at 0.83 mL/kg/hr for six hours

Water: Water by mouth

oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses


Participant Flow:   Overall Study
    Placebo   High Dose Fat Solution   Low Dose Fat Solution   Oral Fat
STARTED   9   6   5   6 
COMPLETED   9   6   5   6 
NOT COMPLETED   0   0   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
Placebo

IV saline with heparin, oral water

Saline: IV saline at 0.83 mL/kg/hr for six hours

Water: Water by mouth

Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours

High Dose Fat Solution

Intralipid at high dose, with heparin and PO water

Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours

Water: Water by mouth

Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours

Low Dose Fat Solution

Low dose IV Intralipid with heparin and PO water

Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours

Water: Water by mouth

Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours

Oral Fat

Oral fat load with IV saline

Saline: IV saline at 0.83 mL/kg/hr for six hours

Water: Water by mouth

oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses

Total Total of all reporting groups

Baseline Measures
   Placebo   High Dose Fat Solution   Low Dose Fat Solution   Oral Fat   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   6   5   6   26 
Age, Customized 
[Units: Years]
Median (Inter-Quartile Range)
 35.3 
 (25.0 to 47.6) 
 29.1 
 (24.2 to 38.7) 
 48.6 
 (44.4 to 54.9) 
 27.6 
 (24.2 to 46.9) 
 35.2 
 (29.5 to 47.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      2  22.2%      1  16.7%      1  20.0%      3  50.0%      7  26.9% 
Male      7  77.8%      5  83.3%      4  80.0%      3  50.0%      19  73.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels   [ Time Frame: Baseline to 6 hours ]

2.  Primary:   Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels   [ Time Frame: Baseline to 6 hours ]

3.  Primary:   Change in Circulating Ghrelin Levels   [ Time Frame: Baseline to 6 hours ]

4.  Primary:   Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels   [ Time Frame: Baseline to 6 hours ]

5.  Secondary:   Change in Circulating Glucose Levels   [ Time Frame: Baseline to 6 hours ]

6.  Secondary:   Change in Circulating Insulin Levels   [ Time Frame: Baseline to 6 hours ]

7.  Secondary:   Change in Circulating Leptin Levels   [ Time Frame: Baseline to 6 hours ]

8.  Secondary:   Change in Circulating Adiponectin Levels   [ Time Frame: Baseline to 6 hours ]

9.  Secondary:   Phosphorylation of STAT3 Pathways Downstream of Leptin After Lipid Administration   [ Time Frame: Baseline to 6 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Christos Manztoros
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-8630
e-mail: cmantzor@bidmc.harvard.edu



Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01520454     History of Changes
Other Study ID Numbers: 2009P000370
Study First Received: January 4, 2012
Results First Received: December 29, 2015
Last Updated: March 16, 2017