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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
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olmesartan Medoxomil First, Then No Drug No Drug First, Then Olmesartan Medoxomil
Hide Arm/Group Description

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

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.
Period Title: First Intervention - 8 Weeks
Started 10 10
Completed 8 8
Not Completed 2 2
Period Title: Second Intervention - 8 Weeks
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Olmesartan Medoxomil First, Then No Drug No Drug First, Then Olmesartan Medoxomil Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
49.25  (9.8) 49.75  (14.2) 49.5  (11.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
4
  50.0%
4
  50.0%
8
  50.0%
Male
4
  50.0%
4
  50.0%
8
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 8 participants 8 participants 16 participants
102.3  (20.9) 90.4  (17.7) 96.3  (19.7)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 8 participants 8 participants 16 participants
34.5  (7.0) 31.5  (6.8) 33.0  (6.9)
Body fat  
Mean (Standard Deviation)
Unit of measure:  Percentage of fat
Number Analyzed 8 participants 8 participants 16 participants
43.9  (10.5) 39.8  (13.5) 41.8  (12.1)
Total fat mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 8 participants 8 participants 16 participants
43.1  (15.1) 34.6  (14.7) 38.8  (15.0)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 8 participants 8 participants 16 participants
133.7  (10.1) 140.6  (12.8) 137.2  (11.7)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 8 participants 8 participants 16 participants
81.0  (5.1) 80.1  (7.9) 80.6  (6.4)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
120.6  (68.5) 106.8  (50.9) 113.7  (53.6)
Total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
199.5  (38.2) 207.8  (20.9) 203.7  (30.1)
HDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
45.5  (9.8) 55.1  (29.0) 50.3  (21.5)
LDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
129.9  (34.9) 131.3  (22.4) 130.6  (31.2)
Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 8 participants 16 participants
95.8  (10.8) 99.1  (13.8) 97.4  (12.0)
1.Primary Outcome
Title Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)
Hide Description Data collected from the intravenous glucose tolerance tests included blood concentrations of glucose and insulin. Glucose was measured immediately on a YSI glucose analyzer and insulin was measured via ELISA colormetric kits once all study samples were collected. To analyze changes in insulin sensitivity, the MINMOD software was used. The MINMOD software uses Bergman's minimal model to determine insulin sensitivity during an intravenous glucose tolerance test. Both glucose and insulin values were inserted at each timepoint collected (33 in total over the 3-hour protocol) and the software was run to generate the insulin sensitivity value at baseline and post-test. This information was then used to calculate the change of insulin sensitivity from baseline to post-testing after each 8-week intervention.
Time Frame Baseline testing to post-testing after 8-week intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results of insulin sensitivity by intravenous glucose tolerance (IVGTT) testing are reported per intervention (Olmesartan Medoxomil and No drug). Only 10 of the 16 study participants who participated in all or some of the study measurements opted to complete or had sufficient data to analyze for each pre- and post-intervention (4 total) IVGTT.
Arm/Group Title Olmesartan Medoxomil No Drug Intervention
Hide Arm/Group Description:

Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.

Olmesartan medoxomil

The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mu/L/min
0.253  (2.7) -0.804  (2.2)
2.Other Pre-specified Outcome
Title Collagen Gene Expression in Skeletal Muscle (Change Over Time)
Hide Description RNA extraction and quantification were determined using an RNeasy Mini Fibrous Kit and DNase I treatment (Qiagen, Valencia, CA, USA) in accordance to the manufacturer’s directions for mRNA extraction. Quantitative real-time polymerase chain reaction (qRT-PCR) measured the expression of collagen III using an ABI PRISM 7900 Sequence Detection System instrument and TaqMan Universal PCR Master Mix according to the manufacturer’s instructions (Applied Biosystems, Foster City, CA, USA). Relative gene expression levels were determined using the number of cycles necessary to reach threshold and results were normalized to cyclophilin B RNA levels.
Time Frame Baseline testing to post-testing after 8-week intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results are reported for the Olmesartan Medoxomil intervention only; there was insufficient RNA yield for the majority of participants during the no drug treatment. Only 7 of the 16 study participants who participated in the study measurements had sufficient data to analyze the pre- and post-intervention skeletal muscle biopsy tissues.
Arm/Group Title Olmesartan Medoxomil
Hide Arm/Group Description:

Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.

Olmesartan medoxomil

Overall Number of Participants Analyzed 7
Mean (Standard Error)
Unit of Measure: Arbitrary unit (AU)
Pre-Olmesartan medoxomil 1491  (510)
Post-Olmesartan medoxomil 774  (271)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olmesartan Medoxomil No Drug Intervention
Hide Arm/Group Description

Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.

Olmesartan medoxomil

The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
All-Cause Mortality
Olmesartan Medoxomil No Drug Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan Medoxomil No Drug Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olmesartan Medoxomil No Drug Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
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
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