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Angiotensin II Blockade and Inflammation in Obesity (ARB)

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ClinicalTrials.gov Identifier: NCT01684748
Recruitment Status : Completed
First Posted : September 13, 2012
Results First Posted : January 12, 2015
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kevin Davy, Virginia Polytechnic Institute and State University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Overweight
Obese
Prehypertension
Hypertension
Intervention: Drug: Olmesartan medoxomil

  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
Olmesartan Medoxomil First, Then No Drug

During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.

Olmesartan medoxomil

No Drug First, Then Olmesartan Medoxomil During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.

Participant Flow for 2 periods

Period 1:   First Intervention - 8 Weeks
    Olmesartan Medoxomil First, Then No Drug   No Drug First, Then Olmesartan Medoxomil
STARTED   10   10 
COMPLETED   8   8 
NOT COMPLETED   2   2 

Period 2:   Second Intervention - 8 Weeks
    Olmesartan Medoxomil First, Then No Drug   No Drug First, Then Olmesartan Medoxomil
STARTED   8   8 
COMPLETED   8   8 
NOT COMPLETED   0   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
Olmesartan Medoxomil First, Then No Drug

During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.

Olmesartan medoxomil

No Drug First, Then Olmesartan Medoxomil During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
Total Total of all reporting groups

Baseline Measures
   Olmesartan Medoxomil First, Then No Drug   No Drug First, Then Olmesartan Medoxomil   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.25  (9.8)   49.75  (14.2)   49.5  (11.8) 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8 100.0%      7  87.5%      15  93.8% 
>=65 years      0   0.0%      1  12.5%      1   6.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  50.0%      4  50.0%      8  50.0% 
Male      4  50.0%      4  50.0%      8  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   8   8   16 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 102.3  (20.9)   90.4  (17.7)   96.3  (19.7) 
Body mass index 
[Units: Kg/m2]
Mean (Standard Deviation)
 34.5  (7.0)   31.5  (6.8)   33.0  (6.9) 
Body fat 
[Units: Percentage of fat]
Mean (Standard Deviation)
 43.9  (10.5)   39.8  (13.5)   41.8  (12.1) 
Total fat mass 
[Units: Kg]
Mean (Standard Deviation)
 43.1  (15.1)   34.6  (14.7)   38.8  (15.0) 
Systolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 133.7  (10.1)   140.6  (12.8)   137.2  (11.7) 
Diastolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 81.0  (5.1)   80.1  (7.9)   80.6  (6.4) 
Triglycerides 
[Units: mg/dL]
Mean (Standard Deviation)
 120.6  (68.5)   106.8  (50.9)   113.7  (53.6) 
Total cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 199.5  (38.2)   207.8  (20.9)   203.7  (30.1) 
HDL cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 45.5  (9.8)   55.1  (29.0)   50.3  (21.5) 
LDL cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 129.9  (34.9)   131.3  (22.4)   130.6  (31.2) 
Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 95.8  (10.8)   99.1  (13.8)   97.4  (12.0) 


  Outcome Measures

1.  Primary:   Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)   [ Time Frame: Baseline testing to post-testing after 8-week intervention ]

2.  Other Pre-specified:   Collagen Gene Expression in Skeletal Muscle (Change Over Time)   [ Time Frame: Baseline testing to post-testing after 8-week intervention ]


  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:  
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: Elaina Marinik, Ph.D.
Organization: Virginia Polytechnic Institute & State University
phone: 5402318299
e-mail: emarinik@vt.edu



Responsible Party: Kevin Davy, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT01684748     History of Changes
Other Study ID Numbers: arbfat
First Submitted: September 6, 2012
First Posted: September 13, 2012
Results First Submitted: May 29, 2014
Results First Posted: January 12, 2015
Last Update Posted: January 3, 2018