Clinical trial NCT03729479: The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Official title: The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type2 Diabetes Mellitus
Hypertension
PreDiabetes
Overweight and Obesity
Keywords: dietary intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 full factorial
Primary purpose: TREATMENT

Brief summary: This study will compare the low-sodium/low-fat DASH (Dietary Approaches to Stop Hypertension) diet with a very low-carbohydrate diet, helping us to better understand how two different dietary approaches may help participants control their blood pressure, lose weight, and reduce their blood glucose.

Detailed description: Adults with overweight or obesity, hypertension, and prediabetes or type 2 diabetes are at a high risk of adverse health outcomes including stroke, renal disease, myocardial infarction, and premature death. Evidence suggests that the first-line treatment for adults with this triple burden should be a comprehensive diet and lifestyle intervention.

However, experts disagree about which diet should be recommended. The Dietary Approaches to Stop Hypertension (DASH) diet, a lower fat diet, is the de facto diet for adults with hypertension. A very low-carbohydrate (VLC) diet, a higher fat diet, is becoming the de facto diet for weight and glycemic control. In addition, a VLC diet may reduce blood pressure through weight loss and its impact on insulin (which alters renal sodium transport and leads to diuresis). Given that these two diets, DASH and very low-carbohydrate, are extremely promising options for this population, and the fact that they have never been compared in this population or any other, this comparison is strongly warranted.

The investigators propose to use an interprofessional team (with expertise in nursing, psychology, medicine, policy, nutrition, pharmacy, and behavioral interventions) to conduct a comparative effectiveness trial of two different diets for adults with this triple burden. The HERO Study (Hypertension, Diabetes, and Obesity Education Research Online) will compare the health effects of the DASH and VLC diets.

The investigators propose one aim:

Test the feasibility, acceptability, and preliminary comparative efficacy of the interventions. The investigators will randomize 140 adults with this triple burden to the DASH or VLC versions of the 4-month intervention. Outcome measures include intervention feasibility (recruitment and retention); acceptability (satisfaction with the intervention); and preliminary comparative efficacy as determined by changes in our primary outcome (systolic blood pressure), as well as exploratory secondary outcomes (weight, glycemic control).

Eligibility criteria: Inclusion Criteria:

1. BMI of 25-50
2. Diagnosis pre-hypertension or hypertension (within the past 6 months) and current resting systolic blood pressure \> 130 mmHg.
3. Diagnosis of either prediabetes or type 2 diabetes, defined as:

   1. HbA1c of at least 5.7% or
   2. Two-hour glucose tolerance test \>140 mg/dL
4. Aged 21-70 years old
5. Access to the internet and text messaging
6. Ability to engage in light physical activity
7. Sufficient control over their food intake to adhere to study diets
8. Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 4-month trial
9. Participation in the trial approved by primary care provider, along with agreement to work with the participant and our research team to manage medication changes

Exclusion Criteria:

1. Non-English speaking
2. Current use of insulin, Dilantin, lithium, and warfarin
3. Inability to complete baseline measurements
4. Severe renal or hepatic insufficiency
5. Cardiovascular dysfunction, including diagnosis of:

   1. Congestive heart failure
   2. Angina
   3. Arrhythmias
   4. Cardiomyopathy
   5. Valvular heart disease
6. Uncontrolled psychiatric disorder
7. Consumes \>30 alcoholic drinks per week
8. Currently undergoing chemotherapy
9. Pregnant or planning to get pregnant in the next 12 months
10. Breastfeeding or less than 6 months' post-partum
11. Planned weight loss surgery or similar surgery performed previously
12. Vegan or vegetarian
13. Currently enrolled in a weight loss program or take weight loss supplements (that are not willing to be stopped before enrolling)
14. Expecting to move out of the area within 12 months
15. Any other medical condition that may make either diet dangerous as determined by the study medical team.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 4 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 4 months
measure: Weight loss
timeFrame: 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: