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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 : June 4, 2019
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
Enrollment 150
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

Period Title: Overall Study
Started 41 39
Completed 40 39
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Exenatide Placebo Total
Hide Arm/Group Description

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 40 39 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 39 participants 79 participants
35.1  (8.4) 33.7  (9.0) 34.4  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
Female
23
  57.5%
23
  59.0%
46
  58.2%
Male
17
  42.5%
16
  41.0%
33
  41.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
African American
1
   2.5%
9
  23.1%
10
  12.7%
White
11
  27.5%
10
  25.6%
21
  26.6%
Hispanic
4
  10.0%
6
  15.4%
10
  12.7%
Native American
22
  55.0%
14
  35.9%
36
  45.6%
Other
2
   5.0%
0
   0.0%
2
   2.5%
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 40 participants 39 participants 79 participants
105.5  (19.2) 108.8  (20.7) 107.1  (19.9)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 39 participants 79 participants
38.0  (6.6) 38.2  (6.8) 38.1  (6.7)
Fat free mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 40 participants 39 participants 79 participants
34.6  (11.5) 37.9  (8.7) 36.3  (12.8)
Fat mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 40 participants 39 participants 79 participants
27.9  (8.8) 30.8  (8.7) 29.4  (8.8)
Body fat  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 40 participants 39 participants 79 participants
44.0  (6.9) 44.4  (8.7) 44.2  (7.8)
Fasting glucose  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 40 participants 39 participants 79 participants
96.9  (8.5) 98.8  (8.8) 97.8  (8.6)
Two-hour glucose  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 40 participants 39 participants 79 participants
139.4  (25.7) 135.1  (25.6) 137.2  (25.6)
Mean energy intake  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
3495.5  (1169.6) 3093.5  (992.3) 3294.5  (1096.3)
Percentage of calories needed for weight maintenance participants consumed  
Mean (Standard Deviation)
Unit of measure:  Percentage of Carlories
Number Analyzed 40 participants 39 participants 79 participants
119.3  (42.1) 105.4  (29.6) 112.3  (36.9)
Carbohydrates intake  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
1785.5  (595.5) 1593.8  (476.1) 1689.7  (544.0)
Fat intake  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
1305.3  (488.4) 1130.9  (484.6) 1218.1  (491.2)
Protein intake  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
434.2  (159.5) 396.9  (139.6) 415.6  (150.1)
Soda intake  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
206.5  (191.3) 183.3  (169.1) 195.0  (159.5)
24 hour energy expenditure  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
2319.3  (377.0) 2333.8  (422.0) 2325.9  (385.3)
Respiratory quotient  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 40 participants 39 participants 79 participants
0.86  (0.03) 0.85  (0.03) 0.86  (0.03)
Carbohydrate oxidation  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
1121.1  (353.5) 1068.4  (322.5) 1097.0  (338.3)
Lipid Oxidation  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
781.0  (330.2) 873.5  (377.6) 823.3  (353.1)
Sleeping metabolic rate  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
1818.1  (277.5) 1800.6  (286.5) 1810.1  (279.7)
Awake fed thermogenesis  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
629.9  (176.3) 671.0  (232.0) 648.7  (203.2)
Spontaneous physical activity  
Mean (Standard Deviation)
Unit of measure:  Kcal/day
Number Analyzed 40 participants 39 participants 79 participants
80.4  (47.1) 79.4  (43.4) 80.0  (45.1)
1.Primary Outcome
Title Energy Intake
Hide Description Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups
Time Frame Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: kcal/day
1016.1  (724.5) 245.1  (710.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -624.8
Confidence Interval (2-Sided) 95%
-901.8 to -347.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Twenty-four-hour Energy Expenditure
Hide Description Change of twenty-four-hour energy expenditure between at Day 5 at baseline assessment and at Day 11 two days after starting study medication between the exenatide and placebo groups
Time Frame Day 5 and Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

Overall Number of Participants Analyzed 38 33
Mean (Standard Deviation)
Unit of Measure: kcal/day
51.6  (157.2) 28.9  (119.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -24
Confidence Interval (2-Sided) 95%
-89.7 to 41.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Body Weight
Hide Description Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

Overall Number of Participants Analyzed 31 33
Mean (Standard Deviation)
Unit of Measure: kg
1.6  (3.15) 0.27  (2.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.48
Confidence Interval (2-Sided) 95%
-3.02 to 0.05
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description

10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss

Twice daily

Metabolic Chamber: The subject stays in the small room

Placebo

All-Cause Mortality
Exenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (0.00%) 
Hide Serious Adverse Events
Exenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   39/40 (97.50%)   39/39 (100.00%) 
Endocrine disorders     
hypoglycemia *  10/40 (25.00%)  3/39 (7.69%) 
Gastrointestinal disorders     
Nausea *  24/40 (60.00%)  19/39 (48.72%) 
Diarrhea *  16/40 (40.00%)  16/39 (41.03%) 
Gastroesophageal reflux *  13/40 (32.50%)  15/39 (38.46%) 
Vomiting *  11/40 (27.50%)  8/39 (20.51%) 
Constipation *  14/40 (35.00%)  9/39 (23.08%) 
General disorders     
Headache *  23/40 (57.50%)  21/39 (53.85%) 
Palpitations  4/40 (10.00%)  5/39 (12.82%) 
Metabolism and nutrition disorders     
hunger decrease *  39/40 (97.50%)  4/39 (10.26%) 
Product Issues     
Injection site reaction *  13/40 (32.50%)  5/39 (12.82%) 
Skin and subcutaneous tissue disorders     
Itchiness *  12/40 (30.00%)  4/39 (10.26%) 
Skin rash  6/40 (15.00%)  1/39 (2.56%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jonathan Krakoff
Organization: National Institutes of Health
Phone: 602-200-5217
EMail: jkrakoff@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00856609    
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: June 4, 2019