The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)

Completed · Phase 1/Phase 2

Conditions studied: Type2 Diabetes Mellitus, Hypertension, PreDiabetes, Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT03729479

Run by

University of Michigan

People needed

94

Starts

2018-11-01

Expected to finish

2020-08-09

Last updated by the study team

2020-09-29

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI of 25-50
• Diagnosis pre-hypertension or hypertension (within the past 6 months) and current resting systolic blood pressure > 130 mmHg.
• Diagnosis of either prediabetes or type 2 diabetes, defined as:
• HbA1c of at least 5.7% or
• Two-hour glucose tolerance test >140 mg/dL
• Aged 21-70 years old
• Access to the internet and text messaging
• Ability to engage in light physical activity
• Sufficient control over their food intake to adhere to study diets
• Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 4-month trial
• 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

You may not qualify if…

• Non-English speaking
• Current use of insulin, Dilantin, lithium, and warfarin
• Inability to complete baseline measurements
• Severe renal or hepatic insufficiency
• Cardiovascular dysfunction, including diagnosis of:
• Congestive heart failure
• Angina
• Arrhythmias
• Cardiomyopathy
• Valvular heart disease
• Uncontrolled psychiatric disorder
• Consumes >30 alcoholic drinks per week
• Currently undergoing chemotherapy
• Pregnant or planning to get pregnant in the next 12 months
• Breastfeeding or less than 6 months' post-partum
• Planned weight loss surgery or similar surgery performed previously
• Vegan or vegetarian
• Currently enrolled in a weight loss program or take weight loss supplements (that are not willing to be stopped before enrolling)
• Expecting to move out of the area within 12 months
• Any other medical condition that may make either diet dangerous as determined by the study medical team.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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