Racial Differences in the Natriuretic Peptide Response to Glucose Challenge

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03072602
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

The purpose of the study is to discover any racial dissimilarity in the response of Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate challenge

Condition or Disease	Intervention/Treatment	Phase
Healthy; Natriuretic Peptides; Metabolic Syndrome	Dietary Supplement: Study diet; Other: Glucose Challenge	N/A

Detailed Description

Previous studies have shown an association between reduced levels of circulating natriuretic peptides (NPs) and obesity in humans. This association is especially pronounced in those with metabolic syndrome traits and elevated plasma insulin. As previously conducted study has shown that an increase in NPs with weight loss in obese individuals is "primary" and not secondary to alteration in cardiac structure or function.

Previous experimental data suggests that Atrial NP (ANP) has a wide range of favorable metabolic effects including that activation of brown fat and improvement in skeletal muscle oxidative capacity and glucose utilization. New evidence suggests that ANP activation directly modulates insulin sensitivity and energy homeostasis, suggesting that ANP suppression could promote more obesity/insulin resistance. Moreover, ANP exerts potent lipolytic effects in vitro and in vivo. The previous study has shown that a high-carbohydrate challenge in healthy volunteers is associated with a reduction in N-terminal-proANP (NTproANP) but not N-terminal-proB-type NP (NTproBNP) levels. Nonetheless our outcomes were predominantly in Caucasians and warrants replication in other racial groups.

There is no data on the ANP response to high-carbohydrate challenge in African Americans, a racial group with disproportionately greater rates of obesity, insulin resistance, and diabetes as compared to Caucasians. So the investigators have proposed to conduct a pilot study in otherwise healthy, normotensive subjects to examine NP system, especially the effects on MRproANP in response of high-carbohydrate challenge.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Each participant will be enrolled into one of the two groups by race.Each participant will be enrolled into one of the two groups by race.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Study of Racial Differences in Natriuretic Peptides Response to Glucose Challenge
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: African-American Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.	Dietary Supplement: Study diet; Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).; Other: Glucose Challenge; Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Active Comparator: White Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.	Dietary Supplement: Study diet; Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).; Other: Glucose Challenge; Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.

Outcome Measures

Primary Outcome Measures

1. Plasma MRproANP [From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days]

   Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)

Secondary Outcome Measures

1. The Difference in Circulating Plasma MRproANP [From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days]

   Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)

2. Serum Insulin [At 1 hour after glucose challenge]

   The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites

3. Serum Glucose [At 1 hour after glucose challenge]

   The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites

4. Plasma NTproBNP [From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days]

   Change in circulating NTproBNP levels in response to glucose challenge in African-Americans and Whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log NTproBNP with 95% CI)

5. Neprilysin [At baseline]

   Circulating plasma neprilysin levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18-40 years

• Blood pressure less than 140/90

• Estimated creatinine clearance >60cc/min

• Willingness to comply with the study diet

Exclusion Criteria:

• History of hypertension

• History of cardiovascular, renal, or liver disease

• Diabetes or use of glucose-lowering medications

• Use of vasoactive or diuretic medications

• Atrial fibrillation

• Anemia (Hematocrit < 41% in men and <35% in women

• Abnormal serum sodium or potassium

• Urine β-HCG consistent with pregnancy

• Abnormal liver function tests (>3x upper limit of normal)

• Women taking hormonal birth control

• Current smokers

• Regular users of non-steroid anti-inflammatory medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Pankaj Arora, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 20, 2021
• Informed Consent Form - Jul 27, 2019

More Information

Publications

• Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.
• Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.
• Wu C, Arora P, Agha O, Hurst LA, Allen K, Nathan DI, Hu D, Jiramongkolchai P, Smith JG, Melander O, Trenson S, Janssens SP, Domian I, Wang TJ, Bloch KD, Buys ES, Bloch DB, Newton-Cheh C. Novel MicroRNA Regulators of Atrial Natriuretic Peptide Production. Mol Cell Biol. 2016 Jun 29;36(14):1977-87. doi: 10.1128/MCB.01114-15. Print 2016 Jul 15.

• Responsible Party: Pankaj Arora, MD, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03072602
• Other Study ID Numbers: X16081002
• First Posted: Mar 7, 2017
• Last Update Posted: Sep 23, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pankaj Arora, MD, Assistant Professor, University of Alabama at Birmingham: Racial differences
• Additional relevant MeSH terms: Metabolic Syndrome

Study Results

Participant Flow

Pre-assignment Detail	A total of 81 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had 7 study dropouts and 2 participants were not able to complete the protocol. A total of 72 participants completed the study.

Arm/Group Title	African American	White
Arm/Group Description	Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours.	Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours.
Period Title: Overall Study
STARTED	39	42
Total Participant Screened for the Purpose of Eligibilty	47	47
Ineligible Participants	8	5
Participant Received Standardized Meals	39	42
Study Dropouts	4	3
Participants Returned for Glucose Challenge Protocol	35	39
Unable to Complete the Protocol	1	1
COMPLETED	34	38
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	African-American	White	Total
Arm/Group Description	Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.	Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.	Total of all reporting groups
Overall Participants	34	38	72
Age, Customized (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	27	26	27
Sex: Female, Male (Count of Participants)
Female	19 55.9%	21 55.3%	40 55.6%
Male	15 44.1%	17 44.7%	32 44.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	34 100%	0 0%	34 47.2%
White	0 0%	38 100%	38 52.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	27	25	26
Systolic Blood Pressure (mmHg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mmHg]	115	112	114
Sodium (mmol/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mmol/L]	139	139	139
Potassium (mmol/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mmol/L]	4.0	4.1	4.1
Creatinine (mmol/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mmol/L]	0.8	0.8	0.8
Percentage of Hematocrit (%) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [%]	40	40	40
Fasting Glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	93.7 (11.6)	93.1 (5.8)	93.4 (9.0)
Fasting Insulin (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	14.3 (18.4)	6.6 (3.6)	10.2 (13.4)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (Ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Ratio]	3.6 (5.8)	1.5 (0.9)	2.5 (4.2)
Mid-regional pro-atrial natriuretic peptide (MRproANP) (pmol/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pmol/L]	43	52	48
B-type natriuretic peptide (BNP) (pg/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pg/mL]	17	22	20
N-terminal pro-B-type natriuretic peptide (NTproBNP) (pg/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pg/mL]	14	33	24

Outcome Measures

1. Primary Outcome

Title	Plasma MRproANP
Description	Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)
Time Frame	From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American
Arm/Group Description	Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Measure Participants	34
Mean (95% Confidence Interval) [Percentage of change]	23

2. Secondary Outcome

Title	The Difference in Circulating Plasma MRproANP
Description	Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)
Time Frame	From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American	Whites
Arm/Group Description	Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.	Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Measure Participants	34	38
Mean (95% Confidence Interval) [Percentage change]	23	34

3. Secondary Outcome

Title	Serum Insulin
Description	The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites
Time Frame	At 1 hour after glucose challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American	Whites
Arm/Group Description	Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.	Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Measure Participants	34	38
Mean (Standard Deviation) [µU/mL]	98.5 (10.1)	69.7 (6.7)

4. Secondary Outcome

Title	Serum Glucose
Description	The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites
Time Frame	At 1 hour after glucose challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American	Whites
Arm/Group Description	Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.	Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Measure Participants	34	38
Mean (Standard Error) [mg/dL]	129.9 (7.3)	126.8 (6.2)

5. Secondary Outcome

Title	Plasma NTproBNP
Description	Change in circulating NTproBNP levels in response to glucose challenge in African-Americans and Whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log NTproBNP with 95% CI)
Time Frame	From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American	Whites
Arm/Group Description	Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.	Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Measure Participants	34	38
Mean (Standard Error) [Percentage]	-1 (0.2)	-3 (0.3)

6. Secondary Outcome

Title	Neprilysin
Description	Circulating plasma neprilysin levels
Time Frame	At baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	5 days
Arm/Group Title	African American		White
Arm/Group Description	Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours.		Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours. Study diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). Glucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours.
All Cause Mortality
	African American		White
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/38 (0%)
Serious Adverse Events
	African American		White
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	African American		White
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.