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DASH Diet for High Blood Pressure (DASH4D Trial)
N/A
Waitlist Available
Led By Nisa Maruthur, MD, MHS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Diabetes Mellitus Type 2 defined by HbA1c ≥6.5% or treatment of diabetes with diabetes medication(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of 5-week feeding period
Awards & highlights
DASH4D Trial Summary
This trial is testing the effects of a DASH-style diet and different sodium levels on blood pressure.
Who is the study for?
Adults with Type 2 Diabetes and blood pressure between 120-159/under 100 mmHg, who can eat on-site meals regularly, have stable weight, no other clinical trials or severe illnesses. Must not be pregnant or planning pregnancy, without significant dietary restrictions that affect adherence.Check my eligibility
What is being tested?
The DASH4D trial is testing the effects of a diabetes-modified DASH diet versus a typical American diet and the impact of low versus high sodium intake on blood pressure in people with Type 2 Diabetes through a controlled feeding study.See study design
What are the potential side effects?
There may not be direct side effects from participating as this trial involves dietary changes rather than medication. However, changes in diet can sometimes cause digestive discomfort or alterations in energy levels.
DASH4D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have Type 2 diabetes with an HbA1c of 6.5% or higher, or I am on diabetes medication.
DASH4D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of 5-week feeding period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of 5-week feeding period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Systolic blood pressure (SBP)
Secondary outcome measures
Cardiovascular disease (CVD) risk percentage
Diastolic blood pressure (DBP)
Fasting glucose level
+11 moreDASH4D Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Comparison diet with higher sodiumExperimental Treatment2 Interventions
Dietary pattern that is typical of what many Americans eat, with sodium level of 3700 mg/day
Group II: DASH4D diet with lower sodiumActive Control2 Interventions
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
Group III: DASH4D diet with higher sodiumActive Control2 Interventions
DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
Group IV: Comparison diet with lower sodiumActive Control2 Interventions
Dietary pattern that is typical of what many Americans eat, with sodium level of 1500 mg/day
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,819,966 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,231 Total Patients Enrolled
Nisa Maruthur, MD, MHSPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot check your own blood sugar levels if necessary.You drink more than 14 alcoholic drinks in a week or more than 6 drinks in one sitting.My kidney function is severely reduced.Your diastolic blood pressure is consistently below 100 mmHg during three screening visits.I am participating in or planning to start a weight loss program.I have lost or gained more than 5% of my weight in the last 2 months.I can eat one meal a day, 3 days a week at the study site and follow the study diet.My arm's circumference is at least 50cm.My medication doses for blood pressure, diabetes, asthma/COPD, hormone therapy, or certain mental health conditions have been stable for the last 2 months.I am not taking specific medications that could affect the trial, or I am willing to adjust them.I haven't had cancer treatment in the last 2 years, except for certain skin, breast, or prostate cancers.I have Type 1 diabetes.I have not had any major heart issues or strokes in the last 6 months.Your HbA1c level is higher than 9.0%.I visited the ER for asthma or COPD in the past 6 months.I have had recent issues with my digestive system, including surgery or inflammation.I needed help or was hospitalized for low blood sugar in the past year.I can video call using my own or a study-provided device.I have food allergies or dietary needs that may affect my diet adherence.You currently have a drug or alcohol problem that would make it difficult for you to take part in the study.Your blood potassium level is too high or too low.I am willing and able to follow the study's testing schedule.You weigh more than 420 pounds.I am 18 years old or older.Your blood pressure is consistently between 120 and 159 mmHg during three screening visits.I have Type 2 diabetes with an HbA1c of 6.5% or higher, or I am on diabetes medication.
Research Study Groups:
This trial has the following groups:- Group 1: DASH4D diet with lower sodium
- Group 2: DASH4D diet with higher sodium
- Group 3: Comparison diet with lower sodium
- Group 4: Comparison diet with higher sodium
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT04286555 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this research initiative for participants?
"The information available on clinicaltrials.gov states that this study is actively enlisting participants, with the initial posting dating from June 2nd 2021 and most recent update occurring 13 days later."
Answered by AI
How many participants are taking part in this research endeavor?
"Affirmative. Clinicaltrials.gov reveals that this medical trial, which was first posted on June 2nd 2021, is actively looking for participants. It needs to acquire 100 volunteers from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
California
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Johns Hopkins ProHealth
Why did patients apply to this trial?
Hope to reduce or eliminate amount of medication for hbp and diabetes though alternative methods.
PatientReceived 2+ prior treatments
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