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Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780870
First Posted: January 31, 2013
Last Update Posted: August 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.
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
Results First Submitted: January 6, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: Obesity
Weight Loss
Intervention: Dietary Supplement: Weight loss group (Full meal replacement products)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Weight Loss Group

Full Meal replacement Protocol

Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase


Participant Flow:   Overall Study
    Control Group   Weight Loss Group
STARTED   0   5 
COMPLETED   0   5 
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.
Due to enrolling problems, no subjects were enrolled to the control group. All the subjects were enrolled to the weight loss group

Reporting Groups
  Description
Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Weight Loss Group

Full Meal replacement Protocol

Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase

Total Total of all reporting groups

Baseline Measures
   Control Group   Weight Loss Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   5   5 
Age 
[Units: Participants]
Count of Participants
     
<=18 years         0   0.0%      0   0.0% 
Between 18 and 65 years         5 100.0%      5 100.0% 
>=65 years         0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
    32.8  (3.1)   32.8  (3.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female         5 100.0%      5 100.0% 
Male         0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States      5   5 


  Outcome Measures
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1.  Primary:   The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks   [ Time Frame: 8 weeks ]

2.  Primary:   The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks   [ Time Frame: 8 weeks ]

3.  Primary:   The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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: Dr. Christos Mantzoros
Organization: Beth Israel Deaconess Medical Center
phone: 6176678633
e-mail: cmantzor@bidmc.harvard.edu



Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01780870     History of Changes
Other Study ID Numbers: 2011P000293
First Submitted: January 29, 2013
First Posted: January 31, 2013
Results First Submitted: January 6, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017