Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084574
• Other study ID #: Pro00102823
• Status: Completed
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: September 27, 2023

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine cultural and disease-related barriers and facilitators to following the Dietary Approaches to Stop Hypertension (DASH) dietary pattern among Black Americans with moderate chronic kidney disease (CKD) and test the impact of a behavioral diet counseling intervention on DASH diet adherence, blood pressure, and CKD-relevant outcomes.

Description:

Excess cardiovascular disease (CVD) mortality among Black Americans with CKD is a significant US public health disparity. Compared to their White counterparts, Blacks develop CKD earlier in life and Blacks with CKD are 3 times more likely to progress to kidney failure necessitating dialysis or kidney transplantation, and are 1.5 times more likely to die prematurely from CVD. Hypertension, which is also more prevalent, more severe, and less often controlled in Blacks with CKD compared to Whites, is a leading cause of CKD and CVD, and a major contributor to the racial disparity in CVD mortality. Thus, improving hypertension in Blacks with CKD could have a profound positive impact on an important minority health issue. The DASH diet lowers BP and reduces CVD risk in patients with hypertension and has a greater effect on BP in Blacks compared to Whites. However, the effect of the DASH diet on BP in Blacks with CKD has not been established. First, investigators will conduct a qualitative study to identify self-perceived barriers and facilitators of DASH diet adherence among Blacks with moderate CKD. Then, investigators will conduct feasibility, acceptability, and preliminary efficacy testing of a disease-sensitive, culturally-appropriate diet counseling intervention on DASH adherence and blood pressure in Blacks with CKD. Prior to the clinical trial portion of this project Qualitative Focus Groups were held to identify self-perceived barriers and facilitators of DASH diet adherence among African Americans with CKD. Three to 4 groups of 6-8 participants were asked semi-structured questions to determine self-perceived sociocultural barriers and facilitators of DASH diet adherence and disease-specific factors that may influence their ability and willingness to follow a DASH-style diet. The information in the rest of this record pertains to the clinical trial portion of the project.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 27, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Black race (self-identified)
• =21 years old
• CKD defined as an eGFR of 30-59 ml/min/1.73m2

Exclusion Criteria:

• History of kidney transplant
• Pregnant of breast-feeding
• Risk factors for hyperkalemia including insulin-dependent diabetes mellitus, diabetes with poor blood glucose control (A1C >10), baseline serum potassium =4.8 mg/dl, and serum bicarbonate <18 mg/dl
• History of hypertension in the preceding 6 months defined as serum potassium greater than 5.1 mg/dl
• Risk for hypotension or severe hypertension (SBP <120 or =180 or DBP =110 mmHg)
• History of kidney transplant
• Lack of English language proficiency

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• High Blood Pressure
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• DASH diet counseling
Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Tyson CC, Barnhart H, Sapp S, Poon V, Lin PH, Svetkey LP. Ambulatory blood pressure in the dash diet trial: Effects of race and albuminuria. J Clin Hypertens (Greenwich). 2018 Feb;20(2):308-314. doi: 10.1111/jch.13170. Epub 2018 Jan 31. — View Citation

Tyson CC, Davenport CA, Lin PH, Scialla JJ, Hall R, Diamantidis CJ, Lunyera J, Bhavsar N, Rebholz CM, Pendergast J, Boulware LE, Svetkey LP. DASH Diet and Blood Pressure Among Black Americans With and Without CKD: The Jackson Heart Study. Am J Hypertens. 2019 Sep 24;32(10):975-982. doi: 10.1093/ajh/hpz090. — View Citation

Tyson CC, Kuchibhatla M, Patel UD, Pun PH, Chang A, Nwankwo C, Joseph MA, Svetkey LP. Impact of Kidney Function on Effects of the Dietary Approaches to Stop Hypertension (Dash) Diet. J Hypertens (Los Angel). 2014;3:1000168. doi: 10.4172/2167-1095.1000168. — View Citation

Tyson CC, Lin PH, Corsino L, Batch BC, Allen J, Sapp S, Barnhart H, Nwankwo C, Burroughs J, Svetkey LP. Short-term effects of the DASH diet in adults with moderate chronic kidney disease: a pilot feeding study. Clin Kidney J. 2016 Aug;9(4):592-8. doi: 10.1093/ckj/sfw046. Epub 2016 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who complete the 12 week intervention program	Completion will be measured by the number of group counseling sessions attended by participants randomized to the treatment arm.	Up to 12 weeks
Primary	Number of participants who complete data collection visits	Completion will be measured by the number of randomized participants who provide blood and urine biospecimens, clinic and 24-hour ambulatory blood pressure measurements, and 24-hour dietary recall data during scheduled data collection visits at baseline, 1 month, 3 months, and 6 months.	Up to 6 months
Primary	Change in 24-hour mean systolic blood pressure during treatment	Change will be measured by comparing the 24-hr mean systolic blood pressures (mmHg) obtained at baseline and at 12 weeks (end of treatment.)	Baseline to 12 weeks
Primary	Change in serum potassium concentration during treatment	Change will measured by comparing serum potassium concentration levels obtained at baseline and at 12 weeks (end of treatment.)	Baseline to 12 weeks
Primary	Change in 24 hour urine concentrations of sodium during treatment	Change will be measured by comparing sodium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)	Baseline to 12 weeks
Primary	Change in 24 hour urine concentrations of potassium during treatment	Change will be measured by comparing potassium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)	Baseline to 12 weeks
Primary	Change in 24 hour urine concentrations of phosphorus during treatment	Change will be measured by comparing phosphorus concentration levels (mg/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)	Baseline to 12 weeks
Primary	Change in 24 hour urine concentrations of urea nitrogen during treatment	Change will be measured by comparing phosphorus concentration levels (g/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)	Baseline to 12 weeks
Secondary	Change in clinic systolic blood pressure during treatment	Change will be measured by comparing clinic systolic blood pressures (mgHH) obtained at baseline and at 12 weeks (end of treatment.)	Baseline to 12 weeks
Secondary	Change in body weight during treatment	Change will be measured by comparing body weights (kg.) obtained at baseline and at 12 weeks (end of treatment.)	Baseline to 12 weeks
Secondary	Change in 24-hour mean systolic blood pressure 3-months post-treatment.	Change will be measured by comparing the 24-hour mean systolic blood pressures (mmHg) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)	12 weeks to 24 weeks
Secondary	Change in body weight 3 months after intervention	Change will be measured by comparing body weights (kg.) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)	12 weeks to 24 weeks
Secondary	Number of participants who sustained their end of treatment DASH diet adherence scores for 3 months after intervention.	Sustained DASH diet scores will be measured by comparing scores derived from 24-hour dietary recall data obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)	12 weeks to 24 weeks