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Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT02034435
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : December 31, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
James Matt Luther, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Metabolic Syndrome
Interventions Other: Low Salt diet plus Placebo tablet
Other: Low Sodium diet plus Salt tablet
Drug: Epleronone
Drug: Amlodipine
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aim1-Low Sodium Then High Sodium Aim 1-High Sodium Then Low Sodium Aim2- Low Sodium Diet and Epleronone Then Amlodipine Aim2- Low Sodium Diet and Amlodipine Then Epleronone
Hide Arm/Group Description

Subjects will be provided with a low sodium diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.

Participants will be given low sodium diet (50mEq/d) and Placebo tablets for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Salt tables (150mEq) for 8days and assessments will be made.

Low Salt diet plus Placebo tablet

Low Sodium diet plus Salt tablet

Subjects will be provided with a diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.

Participants will be given low sodium diet (50mEq/d) and Salt tables (150mEq) for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Placebo tablets for 8days and assessments will be made.

Low Salt diet plus Placebo tablet

Low Sodium diet plus Salt tablet

Subjects on a low salt diet will receive Epleronone 50mg for 8 days and assessments will be made, then cross over to a low salt diet with Amlodipine 5mg for 8days and assessments will be made.

Low Salt diet plus Placebo tablet

Epleronone: 50mg daily

Amlodipine: 5mg daily

Subjects on a low salt diet will receive Amlodipine 5mg for 8 days and assessments will be made, then cross over to a low salt diet with Epleronone 50mg for 8days and assessments will be made.

Low Salt diet plus Placebo tablet

Epleronone: 50mg daily

Amlodipine: 5mg daily

Period Title: Overall Study
Started 13 15 7 9
Aim 1 13 15 0 0
Aim 2 0 0 7 9
Completed 11 13 7 8
Not Completed 2 2 0 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Illness             0             2             0             0
Inadequate IV access             1             0             0             1
Arm/Group Title Aim 1 Aim 2 Total
Hide Arm/Group Description Low Sodium and High Sodium diet crossover Eplerenone and Amlodipine crossover Total of all reporting groups
Overall Number of Baseline Participants 28 16 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 28 participants 16 participants 44 participants
45
(29 to 56)
46
(43 to 56)
45
(40 to 56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
Female
15
  53.6%
6
  37.5%
21
  47.7%
Male
13
  46.4%
10
  62.5%
23
  52.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
28
 100.0%
16
 100.0%
44
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.7%
1
   6.3%
4
   9.1%
White
24
  85.7%
15
  93.8%
39
  88.6%
More than one race
1
   3.6%
0
   0.0%
1
   2.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 16 participants 44 participants
28 16 44
1.Primary Outcome
Title Insulin Secretion
Hide Description Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes
Time Frame After 8 days of diet or drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with metabolic syndrome
Arm/Group Title Aim 1- Low Sodium Aim 1- High Sodium Aim 2- Eplerenone Aim 2- Amlodipine
Hide Arm/Group Description:
Low Sodium diet (50mEq/d)
Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)
Low sodium diet (50mEq/d) plus Eplerenone
Low sodium diet (50mEq/d) plus Amlodipine
Overall Number of Participants Analyzed 28 28 15 16
Median (Inter-Quartile Range)
Unit of Measure: uU/mL*10min
293.1
(186.9 to 369.4)
234.7
(161.3 to 479.7)
330.8
(268.2 to 481.5)
300.4
(177.8 to 477.8)
2.Primary Outcome
Title Insulin Sensitivity
Hide Description Hyperinsulinemic clamp- glucose infusion rate during insulin administration
Time Frame after 8 days of diet or medication
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with metabolic syndrome
Arm/Group Title Aim 1- Low Sodium Aim 1- High Sodium Aim 2- Eplerenone Aim 2- Amlodipine
Hide Arm/Group Description:
Low Sodium diet (50mEq/d)
Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)
Low sodium diet (50mEq/d) plus Eplerenone
Low sodium diet (50mEq/d) plus Amlodipine
Overall Number of Participants Analyzed 28 28 15 16
Median (Inter-Quartile Range)
Unit of Measure: mg/kg/min
6.6
(5.5 to 7.6)
6.9
(6.1 to 7.6)
6.4
(5.8 to 8.2)
6.3
(5.4 to 7.7)
Time Frame Monitoring during 1 week of intervention/drug, washout period, and during cross-over to 1 week of remaining intervention/drug. Monitoring for adverse events continued up to 2 weeks after study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aim 1- Low Sodium Aim 1- High Sodium Aim 2- Eplerenone Aim 2- Amlodipine
Hide Arm/Group Description Low Sodium diet (50mEq/d) Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d) Low sodium diet (50mEq/d) plus Eplerenone Low sodium diet (50mEq/d) plus Amlodipine
All-Cause Mortality
Aim 1- Low Sodium Aim 1- High Sodium Aim 2- Eplerenone Aim 2- Amlodipine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/28 (0.00%)      0/16 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Aim 1- Low Sodium Aim 1- High Sodium Aim 2- Eplerenone Aim 2- Amlodipine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)      0/16 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aim 1- Low Sodium Aim 1- High Sodium Aim 2- Eplerenone Aim 2- Amlodipine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/28 (25.00%)      10/28 (35.71%)      3/16 (18.75%)      3/16 (18.75%)    
Endocrine disorders         
Low glucose * [1]  1/28 (3.57%)  1 1/28 (3.57%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0
Gastrointestinal disorders         
Nausea * [2]  1/28 (3.57%)  1 2/28 (7.14%)  2 1/16 (6.25%)  1 0/16 (0.00%)  0
discomfort with swallowing pill * [3]  0/28 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0
Pain * [4]  0/28 (0.00%)  0 0/28 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1
General disorders         
Dizziness/Lightheadedness *  1/28 (3.57%)  1 1/28 (3.57%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0
Infections and infestations         
viral illness * [5]  1/28 (3.57%)  1 2/28 (7.14%)  2 0/16 (0.00%)  0 0/16 (0.00%)  0
Injury, poisoning and procedural complications         
IV infiltration or malfunction * [6]  0/28 (0.00%)  0 0/28 (0.00%)  0 1/16 (6.25%)  1 2/16 (12.50%)  2
Musculoskeletal and connective tissue disorders         
Cramp *  0/28 (0.00%)  0 1/28 (3.57%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0
Nervous system disorders         
Headache * [7]  2/28 (7.14%)  2 2/28 (7.14%)  2 1/16 (6.25%)  1 0/16 (0.00%)  0
numbness * [8]  1/28 (3.57%)  1 0/28 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
low glucose after clamp, resolved
[2]
Nausea
[3]
temporary discomfort when swallowing tablets
[4]
rectal fissure
[5]
Unrelated viral or other illness
[6]
bruising, swelling, or pain at IV site
[7]
Headache during study
[8]
temporary numbess in hand, resolved spontaneously
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
Layout table for Results Point of Contact information
Name/Title: Dr. James M. Luther, MD
Organization: Vanderbilt University Medical Center
Phone: (615) 936-3420
EMail: james.luther@vumc.org
Layout table for additonal information
Responsible Party: James Matt Luther, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02034435    
Other Study ID Numbers: 131139
First Submitted: January 9, 2014
First Posted: January 13, 2014
Results First Submitted: December 6, 2020
Results First Posted: December 31, 2020
Last Update Posted: January 20, 2021