Trial Outcomes & Findings for Racial Differences in the Natriuretic Peptide Response to Glucose Challenge (NCT NCT03072602)
NCT ID: NCT03072602
Last Updated: 2023-06-22
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days
Results posted on
2023-06-22
Participant Flow
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.
Participant milestones
| Measure |
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 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.
|
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
42
|
|
Overall Study
Total Participant Screened for the Purpose of Eligibilty
|
47
|
47
|
|
Overall Study
Ineligible Participants
|
8
|
5
|
|
Overall Study
Participant Received Standardized Meals
|
39
|
42
|
|
Overall Study
Study Dropouts
|
4
|
3
|
|
Overall Study
Participants Returned for Glucose Challenge Protocol
|
35
|
39
|
|
Overall Study
Unable to Complete the Protocol
|
1
|
1
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Racial Differences in the Natriuretic Peptide Response to Glucose Challenge
Baseline characteristics by cohort
| Measure |
African-American
n=34 Participants
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.
|
White
n=38 Participants
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
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
27 years
n=93 Participants
|
26 years
n=4 Participants
|
27 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Body Mass Index
|
27 kg/m^2
n=93 Participants
|
25 kg/m^2
n=4 Participants
|
26 kg/m^2
n=27 Participants
|
|
Systolic Blood Pressure
|
115 mmHg
n=93 Participants
|
112 mmHg
n=4 Participants
|
114 mmHg
n=27 Participants
|
|
Sodium
|
139 mmol/L
n=93 Participants
|
139 mmol/L
n=4 Participants
|
139 mmol/L
n=27 Participants
|
|
Potassium
|
4.0 mmol/L
n=93 Participants
|
4.1 mmol/L
n=4 Participants
|
4.1 mmol/L
n=27 Participants
|
|
Creatinine
|
0.8 mmol/L
n=93 Participants
|
0.8 mmol/L
n=4 Participants
|
0.8 mmol/L
n=27 Participants
|
|
Percentage of Hematocrit
|
40 %
n=93 Participants
|
40 %
n=4 Participants
|
40 %
n=27 Participants
|
|
Fasting Glucose
|
93.7 mg/dL
STANDARD_DEVIATION 11.6 • n=93 Participants
|
93.1 mg/dL
STANDARD_DEVIATION 5.8 • n=4 Participants
|
93.4 mg/dL
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Fasting Insulin
|
14.3 mg/dL
STANDARD_DEVIATION 18.4 • n=93 Participants
|
6.6 mg/dL
STANDARD_DEVIATION 3.6 • n=4 Participants
|
10.2 mg/dL
STANDARD_DEVIATION 13.4 • n=27 Participants
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
|
3.6 Ratio
STANDARD_DEVIATION 5.8 • n=93 Participants
|
1.5 Ratio
STANDARD_DEVIATION 0.9 • n=4 Participants
|
2.5 Ratio
STANDARD_DEVIATION 4.2 • n=27 Participants
|
|
Mid-regional pro-atrial natriuretic peptide (MRproANP)
|
43 pmol/L
n=93 Participants
|
52 pmol/L
n=4 Participants
|
48 pmol/L
n=27 Participants
|
|
B-type natriuretic peptide (BNP)
|
17 pg/mL
n=93 Participants
|
22 pg/mL
n=4 Participants
|
20 pg/mL
n=27 Participants
|
|
N-terminal pro-B-type natriuretic peptide (NTproBNP)
|
14 pg/mL
n=93 Participants
|
33 pg/mL
n=4 Participants
|
24 pg/mL
n=27 Participants
|
PRIMARY outcome
Timeframe: From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 daysChange 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)
Outcome measures
| Measure |
African-American
n=34 Participants
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.
|
Whites
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.
|
|---|---|---|
|
Plasma MRproANP
|
23 Percentage of change
Interval 19.0 to 27.0
|
—
|
SECONDARY outcome
Timeframe: From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 daysChange 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)
Outcome measures
| Measure |
African-American
n=34 Participants
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.
|
Whites
n=38 Participants
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.
|
|---|---|---|
|
The Difference in Circulating Plasma MRproANP
|
23 Percentage change
Interval 19.0 to 27.0
|
34 Percentage change
Interval 31.0 to 38.0
|
SECONDARY outcome
Timeframe: At 1 hour after glucose challengeThe difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites
Outcome measures
| Measure |
African-American
n=34 Participants
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.
|
Whites
n=38 Participants
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.
|
|---|---|---|
|
Serum Insulin
|
98.5 µU/mL
Standard Deviation 10.1
|
69.7 µU/mL
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: At 1 hour after glucose challengeThe difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites
Outcome measures
| Measure |
African-American
n=34 Participants
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.
|
Whites
n=38 Participants
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.
|
|---|---|---|
|
Serum Glucose
|
129.9 mg/dL
Standard Error 7.3
|
126.8 mg/dL
Standard Error 6.2
|
SECONDARY outcome
Timeframe: From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 daysChange 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)
Outcome measures
| Measure |
African-American
n=34 Participants
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.
|
Whites
n=38 Participants
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.
|
|---|---|---|
|
Plasma NTproBNP
|
-1 Percentage
Standard Error 0.2
|
-3 Percentage
Standard Error 0.3
|
SECONDARY outcome
Timeframe: At baselineThe relative circulating Neprilysin (Membrane Metalloendopeptidase) mRNA quantification (fold change) at baseline between African-Americans and Whites
Outcome measures
| Measure |
African-American
n=20 Participants
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.
|
Whites
n=29 Participants
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.
|
|---|---|---|
|
Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites
|
3.4 fold change
Standard Error 0.79
|
1.0 fold change
Standard Error 0.15
|
Adverse Events
African American
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
White
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place