Trial Outcomes & Findings for The Diurnal Rhythm in Natriuretic Peptide Levels (NCT NCT03834168)
NCT ID: NCT03834168
Last Updated: 2024-02-05
Results Overview
Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
About 24 hours on the in-patient study visit day after consuming study meals for 5 days
Results posted on
2024-02-05
Participant Flow
A total of 42 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had one study dropout and one participant was not able to complete the protocol. A total of 40 participants completed the study.
Participant milestones
| Measure |
Lean
Healthy self-identified African-American and white male lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
Obese
Healthy self-identified African-American and white male obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
Total Participant Screened for the Purpose of Eligibility
|
22
|
30
|
|
Overall Study
Ineligible Participants
|
3
|
7
|
|
Overall Study
Unable to Complete the Protocol
|
0
|
1
|
|
Overall Study
Study Dropouts
|
1
|
0
|
|
Overall Study
Participants Received 5 Days of Standardized Meals
|
19
|
23
|
|
Overall Study
Participants Returned for the 24-h Inpatient Protocol
|
18
|
23
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Diurnal Rhythm in Natriuretic Peptide Levels
Baseline characteristics by cohort
| Measure |
Lean
n=18 Participants
Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
Obese
n=22 Participants
Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
n=99 Participants
|
33.0 years
n=107 Participants
|
31.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index
|
24.3 kg/m^2
n=99 Participants
|
32.2 kg/m^2
n=107 Participants
|
29.6 kg/m^2
n=206 Participants
|
|
Hip circumference
|
97.3 cm
n=99 Participants
|
111.4 cm
n=107 Participants
|
106.1 cm
n=206 Participants
|
|
Waist circumference
|
76.9 cm
n=99 Participants
|
103.6 cm
n=107 Participants
|
97.6 cm
n=206 Participants
|
|
Systolic Blood Pressure
|
110.7 mmHg
n=99 Participants
|
116.5 mmHg
n=107 Participants
|
116.2 mmHg
n=206 Participants
|
|
Diastolic Blood Pressure
|
69.5 mmHg
n=99 Participants
|
73.7 mmHg
n=107 Participants
|
71.0 mmHg
n=206 Participants
|
|
Heart rate
|
76.5 beats/min
n=99 Participants
|
77.0 beats/min
n=107 Participants
|
77.0 beats/min
n=206 Participants
|
|
Fasting Glucose
|
85.0 mg/dL
n=99 Participants
|
91.5 mg/dL
n=107 Participants
|
87.5 mg/dL
n=206 Participants
|
|
Renal Function
Blood Urea Nitrogen (BUN)
|
12.0 mg/dL
n=99 Participants
|
12.0 mg/dL
n=107 Participants
|
12 mg/dL
n=206 Participants
|
|
Renal Function
Serum Creatinine
|
0.9 mg/dL
n=99 Participants
|
0.9 mg/dL
n=107 Participants
|
0.9 mg/dL
n=206 Participants
|
|
Serum Electrolytes
Sodium, mEq/L
|
137.5 mEq/L
n=99 Participants
|
138.0 mEq/L
n=107 Participants
|
138.0 mEq/L
n=206 Participants
|
|
Serum Electrolytes
Potassium, mEq/L
|
4.2 mEq/L
n=99 Participants
|
4.2 mEq/L
n=107 Participants
|
4.2 mEq/L
n=206 Participants
|
|
Serum Electrolytes
Chloride, mEq/L
|
102.5 mEq/L
n=99 Participants
|
103.5 mEq/L
n=107 Participants
|
103.0 mEq/L
n=206 Participants
|
|
Serum Electrolytes
Bicarbonate, mEq/L
|
26.0 mEq/L
n=99 Participants
|
26.0 mEq/L
n=107 Participants
|
26.0 mEq/L
n=206 Participants
|
|
Serum Calcium
|
9.6 mg/dL
n=99 Participants
|
9.6 mg/dL
n=107 Participants
|
9.6 mg/dL
n=206 Participants
|
|
Liver Function
Total bilirubin
|
0.5 mg/dL
n=99 Participants
|
0.5 mg/dL
n=107 Participants
|
0.5 mg/dL
n=206 Participants
|
|
Liver Function
Alanine transaminase (ALT)
|
13.5 mg/dL
n=99 Participants
|
17.0 mg/dL
n=107 Participants
|
14.0 mg/dL
n=206 Participants
|
|
Liver Function
Aspartate transaminase (AST)
|
17.0 mg/dL
n=99 Participants
|
17.0 mg/dL
n=107 Participants
|
17.0 mg/dL
n=206 Participants
|
|
Liver Function
Gamma-glutamyl transferase (GGT)
|
16.0 mg/dL
n=99 Participants
|
22.5 mg/dL
n=107 Participants
|
20.0 mg/dL
n=206 Participants
|
|
Hematological Parameters
WBC, * 10,000/mm3
|
5.3 cells*10,000/mm^3
n=99 Participants
|
5.5 cells*10,000/mm^3
n=107 Participants
|
5.4 cells*10,000/mm^3
n=206 Participants
|
|
Hematological Parameters
RBC, * 1,000,000/mm3
|
4.7 cells*10,000/mm^3
n=99 Participants
|
4.7 cells*10,000/mm^3
n=107 Participants
|
4.7 cells*10,000/mm^3
n=206 Participants
|
|
Hematological Parameters
Platelet, * 100,000/mm3
|
217.7 cells*10,000/mm^3
n=99 Participants
|
248.7 cells*10,000/mm^3
n=107 Participants
|
243.4 cells*10,000/mm^3
n=206 Participants
|
|
Hemoglobin
|
14.0 g/dL
n=99 Participants
|
14.2 g/dL
n=107 Participants
|
14.2 g/dL
n=206 Participants
|
|
Hematocrit
|
40.5 %
n=99 Participants
|
41.0 %
n=107 Participants
|
41.0 %
n=206 Participants
|
|
Mean Corpuscular Volume (MCV)
|
87.5 fl
n=99 Participants
|
89.0 fl
n=107 Participants
|
88.0 fl
n=206 Participants
|
|
Mean Corpuscular Hemoglobin (MCH)
|
30.0 pg
n=99 Participants
|
31.0 pg
n=107 Participants
|
30.0 pg
n=206 Participants
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
|
34.0 g/dL
n=99 Participants
|
34.0 g/dL
n=107 Participants
|
34.0 g/dL
n=206 Participants
|
|
Red Cell Distribution Width (RDW)
|
13.5 %
n=99 Participants
|
13.3 %
n=107 Participants
|
13.5 %
n=206 Participants
|
|
Mean Platelet Volume (MPV)
|
9.0 fL
n=99 Participants
|
8.0 fL
n=107 Participants
|
9.0 fL
n=206 Participants
|
PRIMARY outcome
Timeframe: About 24 hours on the in-patient study visit day after consuming study meals for 5 daysAssess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals
Outcome measures
| Measure |
Lean
n=18 Participants
Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
Obese
n=22 Participants
Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
|---|---|---|
|
Plasma MRproANP
|
17.92 pmol/l
Interval 12.94 to 25.21
|
15.51 pmol/l
Interval 10.61 to 22.02
|
SECONDARY outcome
Timeframe: About 24 hours on the in-patient study visit day after consuming study meals for 5 daysAssess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race
Outcome measures
| Measure |
Lean
n=18 Participants
Healthy self-identified African-American and white lean participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
Obese
n=22 Participants
Healthy self-identified African-American and white obese participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).
standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
|
|---|---|---|
|
Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm
|
-0.7 Hours
Standard Error 0.03
|
-4.9 Hours
Standard Error 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: About 24 hours on the in-patient study visit day after consuming study meals for 5 daysPopulation: The race-specific analysis was not done for this study
Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals
Outcome measures
Outcome data not reported
Adverse Events
Lean
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese
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