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Trial record 84 of 1360 for:    Area Under Curve AND tablet

The Effects of Potassium on Glucose Metabolism in African Americans

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ClinicalTrials.gov Identifier: NCT02236598
Recruitment Status : Completed
First Posted : September 10, 2014
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Borderline Hypokalemia
Interventions Drug: K+ supplement
Drug: Placebo
Enrollment 61
Recruitment Details  
Pre-assignment Details 61 participants (17%) expressed interested in the study and signed informed consent. Of these, 29 participants were deemed eligible based on the results of the screening labs
Arm/Group Title K+ Supplementation Placebo
Hide Arm/Group Description

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

Period Title: Overall Study
Started 15 14
Completed 15 12
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             1
Arm/Group Title K+ Supplementation Placebo Total
Hide Arm/Group Description

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 15 12 27
Hide Baseline Analysis Population Description
14 participants started in the placebo arm, but only 12 completed and included in the Baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 12 participants 27 participants
56.9  (11.0) 52.7  (8.9) 55.0  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Female
10
  66.7%
8
  66.7%
18
  66.7%
Male
5
  33.3%
4
  33.3%
9
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 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
15
 100.0%
12
 100.0%
27
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
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 15 participants 12 participants 27 participants
15 12 27
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 15 participants 12 participants 27 participants
34.3  (5.4) 35.1  (5.2) 34.8  (5.3)
1.Primary Outcome
Title Change in Glucose Tolerance as Measured by Area-under-the-curve
Hide Description Change in glucose tolerance, as measured by change in glucose area-under-the-curve (Area Under the Curve (AUC) – measured via the trapezoidal method) of 2 hours from the 3-hour Oral Glucose Tolerance Test (OGTT).
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title K+ Supplementation Placebo
Hide Arm/Group Description:

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: AUC - mg*min/dL
328  (1779) 1000  (2378)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection K+ Supplementation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5582
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL
Hide Description Changes in fasting, 1-hour, and 2-hour post-challenge glucose levels in mg/dL
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title K+ Supplementation Placebo
Hide Arm/Group Description:

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change in Fasting Glucose -1.0667  (8.3961) 6.0833  (7.6093)
Change in 1-Hour Glucose 0.80  (31.36) 14.17  (37.07)
Change in 2-Hour Glucose 3.60  (25.82) 0.75  (24.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection K+ Supplementation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Change in Fasting Glucose
Statistical Test of Hypothesis P-Value 0.0963
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection K+ Supplementation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Change in 1-hour Glucose
Statistical Test of Hypothesis P-Value 0.6671
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection K+ Supplementation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Change in 2-hour Glucose
Statistical Test of Hypothesis P-Value 0.7913
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Insulin Secretion as Measured by 2-hour Insulin Area-under-the-curve (AUC)
Hide Description Changes in Insulin Secretion as measured by 2-hour insulin area-under-the-curve (AUC – measured via the trapezoidal method) of 2 hours from the 3-hour OGTT.
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title K+ Supplementation Placebo
Hide Arm/Group Description:

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: AUC - pg*min/mL
71,444  (213,221) 149,327  (378,900)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection K+ Supplementation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5294
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Changes in Insulin Sensitivity
Hide Description Matsuda Insulin Sensitivity Index was calculated as: 10,000 / square root of [fasting glucose x fasting insulin x mean glucose x mean insulin during Oral Glucose Tolerance Test]).
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title K+ Supplementation Placebo
Hide Arm/Group Description:

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: AUC - unitless,
-0.03  (1.49) -0.87  (1.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection K+ Supplementation, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1604
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame The reporting period for SAEs is from the day of randomization and receipt of study medication through 12-week end-of-study visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title K+ Supplementation Placebo
Hide Arm/Group Description

K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months

K+ supplement

Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months

Subjects will be instructed to take the pills

Placebo

All-Cause Mortality
K+ Supplementation Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
K+ Supplementation Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
K+ Supplementation Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/14 (7.14%)    
General disorders     
Vasovagal Syncope  0/15 (0.00%)  0 1/14 (7.14%)  1
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: Ranee Chatterjee Montgomery, M.D.
Organization: Duke University Health System
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02236598     History of Changes
Other Study ID Numbers: Pro00056374
First Submitted: September 8, 2014
First Posted: September 10, 2014
Results First Submitted: February 14, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017