Dietary Approaches to Stop Hypertension for Diabetes
关键词
抽象
描述
In persons with and without diabetes, elevated blood pressure (BP) is the leading cause of stroke and a major risk factor for other cardiovascular diseases, including coronary heart disease and heart failure. Strategies that effectively lower BP include drug therapy and lifestyle modification. Lifestyle modifications, particularly dietary approaches, have been shown to lower BP in persons without diabetes. However, there is a striking dearth of evidence on BP-lowering, lifestyle modifications, other than weight loss, in persons with diabetes. The DASH4D trial is designed to provide this evidence.
The DASH4D trial builds upon the investigators' experience in four NIH-sponsored feeding studies (DASH, DASH-Sodium, OmniHeart, and OmniCarb). The trial will enroll approximately 100 adults with Type 2 diabetes, systolic BP 120-159 mmHg, and diastolic BP <100 mmHg, to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet (typical of what many Americans eat) and (b) lower sodium intake vs. higher sodium intake on BP.
The core design is a four-period, single-site, crossover feeding study with 5-week periods. Participants are fed each of four isocaloric diets, presented in random order:
1. DASH4D diet with lower sodium
2. DASH4D diet with higher sodium
3. comparison diet with lower sodium
4. comparison diet with higher sodium.
The primary contrast of interest is the DASH4D diet with lower sodium vs. the comparison diet with higher sodium.
The DASH4D diet is similar to the original DASH diet, but is lower in carbohydrates and higher in unsaturated fat than the original DASH diet, and therefore, is more consistent with dietary recommendations for persons with diabetes than the original DASH diet. The comparison diet reflects what many persons with diabetes currently consume. The lower sodium intake of approximately 1500 mg/day (at 2000 kcal) has been shown to lower BP in persons without diabetes, and has been recommended in some dietary guidelines. The higher sodium intake of approximately 3700 mg/day (at 2000 kcal) is based on estimated average intake in the US.
Outcomes are measured at the end of each feeding period. The primary outcome is end-of-period, office-based systolic BP. Other outcomes are diastolic BP, measures of glycemia, plasma lipid risk factors, patient symptoms, and estimated cardiovascular disease risk.
Similar to the investigators' prior feeding studies, the investigators expect that the results of the DASH4D trial will be immediately applicable to public health and clinical guidelines and will influence nutrition policy. Furthermore, the trial will provide a rigorous platform to assess the impact of diet and sodium intake on a diverse array of other outcomes in persons with Type 2 diabetes.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 02/24/2020 |
| 提交的预估入学人数: | 02/24/2020 |
| 首次发布: | 02/26/2020 |
| 上次提交的更新: | 06/21/2020 |
| 最近更新发布: | 06/22/2020 |
| 实际学习开始日期: | 09/29/2020 |
| 预计主要完成日期: | 03/30/2023 |
| 预计完成日期: | 03/30/2023 |
状况或疾病
干预/治疗
Other: DASH4D diet
Other: comparison diet
Other: higher sodium
Other: lower sodium
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: DASH4D diet with lower sodium DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day | |
| Active Comparator: DASH4D diet with higher sodium DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day | |
| Active Comparator: Comparison diet with lower sodium Dietary pattern that is typical of what many Americans eat, with sodium level of 1500 mg/day | |
| Other: Comparison diet with higher sodium Dietary pattern that is typical of what many Americans eat, with sodium level of 3700 mg/day |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | INCLUSION CRITERIA: - Age 18 or older - Diabetes Mellitus Type 2 defined by HbA1c ≥6.5% or treatment of diabetes with diabetes medication(s) - Baseline systolic BP of 120-159 mmHg (based on average across 3 screening visits) - Baseline diastolic BP <100 mmHg (based on average across 3 screening visits) - Willing and able to eat on site for one meal per day, 3 days per week, and eat only and all food provided as part of the study diets during the controlled feeding periods (run-in and four 5-week feeding periods) - Willing and able to complete required measurement procedures EXCLUSION CRITERIA: - Laboratory Exclusions - Serum potassium ≥5.2 mmol/L or <3.5 mmol/L - Estimated glomerular filtration rate (eGFR) <30 mL/min by either the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation or the simplified Modification of Diet in Renal Disease Study (MDRD) equation - HbA1c>9.0% - Medication Exclusions 1. Unstable dose (i.e., change in the 2 months prior to screening) of any of the following: - Anti-hypertensive medications - Sodium-glucose co-transporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists - Stimulants, including oral medications for asthma or chronic obstructive pulmonary disease (COPD) - Hormone replacement therapy or thyroid hormone - Weight-increasing psychotropic agents, including antipsychotic agents, lithium, and mirtazapine 2. Use of any of the following medications: - Potassium supplement, except if part of a multivitamin - Prandial or short-acting insulin - GLP-1 receptor agonist if on weight loss dose - Warfarin (Coumadin) - Chronic oral corticosteroid (intermittent use is okay) - Weight loss medications 3. Unwillingness to keep same dose of vitamin, mineral, and botanical supplements 4. Any medication not compatible with participation as determined by the investigators - Medical History Exclusions - Type 1 diabetes - Hypoglycemia requiring hospitalization or the assistance of another person in the last 12 months - Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission - Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate cancer not requiring systemic therapy is acceptable) - Active inflammatory bowel disease, bowel resection, malabsorptive syndrome, pancreatitis (episode within past year), or history of bariatric surgery - Pregnancy or lactation or planned pregnancy - Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months - Any other serious illness or condition not compatible with participation as determined by the investigators - Physical Exclusions - Body weight >420 pounds - Arm circumference ≥50cm - Weight loss or gain of >5.0% of body weight during prior 2 months - Lifestyle and Other Exclusions - Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence - Not able to self-monitor glucose if needed - Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week - Active substance use disorder that would interfere with participation - Participation in or planning to start weight loss program - Current participation in another clinical trial - Planning to leave area prior to end of study - Investigator discretion |
结果
主要结果指标
1. Systolic blood pressure (SBP) [At the end of 5-week feeding period]
次要成果指标
1. Diastolic blood pressure (DBP) [At the end of 5-week feeding period]
2. Glycated albumin level [At the end of 5-week feeding period]
3. Fructosamine level [At the end of 5-week feeding period]
4. Fasting glucose level [At the end of 5-week feeding period]
5. Hemoglobin A1c (HbA1c) level [At the end of 5-week feeding period]
6. Cardiovascular disease (CVD) risk percentage [At the end of 5-week feeding period]
7. Total cholesterol level [At the end of 5-week feeding period]
8. Low-density lipoprotein (LDL) cholesterol level [At the end of 5-week feeding period]
9. High-density lipoprotein (HDL) cholesterol level [At the end of 5-week feeding period]
10. Triglyceride level [At the end of 5-week feeding period]
11. Presence of orthostatic hypotension [At the end of 5-week feeding period]
12. Postural change in systolic blood pressure [At the end of 5-week feeding period]
13. Postural change in diastolic blood pressure [At the end of 5-week feeding period]
14. Symptoms experienced by participants as assessed by a questionnaire [At the end of 5-week feeding period]
