Chronic Kidney Diseases Clinical Trial
Official title:
Diet and Hypertension Management in African Americans With Chronic Kidney Disease
Verified date | January 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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
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 |
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