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The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

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ClinicalTrials.gov Identifier: NCT00856609
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Weight Loss
Obesity
Interventions: Drug: Byetta (exenatide)
Behavioral: Weight loss
Other: Metabolic Chamber
Drug: Placebo

  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
Out of 150 planned total number of enrollment, 145 participants were recruited. Among the 145 participants, 84 participants met inclusion criteria. Only 80 participants out of 84 were randomized.

Reporting Groups
  Description
Exenatide

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Placebo

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo


Participant Flow:   Overall Study
    Exenatide   Placebo
STARTED   41   39 
COMPLETED   40   39 
NOT COMPLETED   1   0 
Adverse Event                1                0 



  Baseline Characteristics

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
Exenatide

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Placebo

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

Total Total of all reporting groups

Baseline Measures
   Exenatide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   39   79 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.1  (8.4)   33.7  (9.0)   34.4  (8.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  57.5%      23  59.0%      46  58.2% 
Male      17  42.5%      16  41.0%      33  41.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
African American   1   9   10 
White   11   10   21 
Hispanic   4   6   10 
Native American   22   14   36 
Other   2   0   2 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 105.5  (19.2)   108.8  (20.7)   107.1  (19.9) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 38.0  (6.6)   38.2  (6.8)   38.1  (6.7) 
Fat free mass 
[Units: Kg]
Mean (Standard Deviation)
 34.6  (11.5)   37.9  (8.7)   36.3  (12.8) 
Fat mass 
[Units: Kg]
Mean (Standard Deviation)
 27.9  (8.8)   30.8  (8.7)   29.4  (8.8) 
Body fat 
[Units: Percent]
Mean (Standard Deviation)
 44.0  (6.9)   44.4  (8.7)   44.2  (7.8) 
Fasting glucose 
[Units: Mg/dl]
Mean (Standard Deviation)
 96.9  (8.5)   98.8  (8.8)   97.8  (8.6) 
Two-hour glucose 
[Units: Mg/dl]
Mean (Standard Deviation)
 139.4  (25.7)   135.1  (25.6)   137.2  (25.6) 
Mean energy intake 
[Units: Kcal/day]
Mean (Standard Deviation)
 3495.5  (1169.6)   3093.5  (992.3)   3294.5  (1096.3) 
Percentage of calories needed for weight maintenance participants consumed 
[Units: Percentage of Carlories]
Mean (Standard Deviation)
 119.3  (42.1)   105.4  (29.6)   112.3  (36.9) 
Carbohydrates intake 
[Units: Kcal/day]
Mean (Standard Deviation)
 1785.5  (595.5)   1593.8  (476.1)   1689.7  (544.0) 
Fat intake 
[Units: Kcal/day]
Mean (Standard Deviation)
 1305.3  (488.4)   1130.9  (484.6)   1218.1  (491.2) 
Protein intake 
[Units: Kcal/day]
Mean (Standard Deviation)
 434.2  (159.5)   396.9  (139.6)   415.6  (150.1) 
Soda intake 
[Units: Kcal/day]
Mean (Standard Deviation)
 206.5  (191.3)   183.3  (169.1)   195.0  (159.5) 
24 hour energy expenditure 
[Units: Kcal/day]
Mean (Standard Deviation)
 2319.3  (377.0)   2333.8  (422.0)   2325.9  (385.3) 
Respiratory quotient 
[Units: Ratio]
Mean (Standard Deviation)
 0.86  (0.03)   0.85  (0.03)   0.86  (0.03) 
Carbohydrate oxidation 
[Units: Kcal/day]
Mean (Standard Deviation)
 1121.1  (353.5)   1068.4  (322.5)   1097.0  (338.3) 
Lipid Oxidation 
[Units: Kcal/day]
Mean (Standard Deviation)
 781.0  (330.2)   873.5  (377.6)   823.3  (353.1) 
Sleeping metabolic rate 
[Units: Kcal/day]
Mean (Standard Deviation)
 1818.1  (277.5)   1800.6  (286.5)   1810.1  (279.7) 
Awake fed thermogenesis 
[Units: Kcal/day]
Mean (Standard Deviation)
 629.9  (176.3)   671.0  (232.0)   648.7  (203.2) 
Spontaneous physical activity 
[Units: Kcal/day]
Mean (Standard Deviation)
 80.4  (47.1)   79.4  (43.4)   80.0  (45.1) 


  Outcome Measures

1.  Primary:   Energy Intake   [ Time Frame: Day 6-7-8 (at baseline) and Day 2-13-14 (3 days after starting study intervention) ]

2.  Primary:   Twenty-four-hour Energy Expenditure   [ Time Frame: Day 5 and Day 11 ]

3.  Secondary:   Body Weight   [ Time Frame: 5 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Results Point of Contact:  
Name/Title: Dr. Jonathan Krakoff
Organization: National Institutes of Health
phone: 602-200-5217
e-mail: jkrakoff@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00856609     History of Changes
Other Study ID Numbers: 999909095
09-DK-N095
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: September 18, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018