Type2 Diabetes MellitusPhase 1/2NCT03729479
The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
A Phase 1/2 study testing DASH diet, Very low carbohydrate, ketogenic diet and Extras in people with Type2 Diabetes Mellitus and Hypertension, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Hypertension, PreDiabetes
- What is being tested?
- DASH diet, Very low carbohydrate, ketogenic diet and Extras
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 9 Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- DASH diet, Very low carbohydrate, ketogenic diet, Extras
- Keywords
- dietary intervention
- Medical subject headings
- Hypertension, Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietBehavioural
Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted).
Very low carbohydrate, ketogenic dietBehavioural
Participants will be taught to follow a very low-carbohydrate diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted).
ExtrasBehavioural
Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: DASH diet | Experimental | Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted). Receives: Behavioral: DASH diet |
| Experimental: very low carbohydrate, ketogenic diet | Experimental | Participants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted). Receives: Behavioral: Very low carbohydrate, ketogenic diet |
| Experimental: DASH diet and extra support | Experimental | Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted).
They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. Receives: Behavioral: DASH diet; Behavioral: Extras |
| Experimental: very low carb, ketogenic diet and extra support | Experimental | Participants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted).
They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. Receives: Behavioral: Very low carbohydrate, ketogenic diet; Behavioral: Extras |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured with sphygmomanometer, assessed as change in blood pressure (systolic and diastolic blood pressure will both be measured, but systolic blood pressure is the main outcome)
Measured: 4 months
Secondary outcomes (2)
Glycemic control
Measured with HbA1c, assessed as change in HbA1c
Measured: 4 months
Weight loss
Measured by body weight scale, assessed as change in percent body weight lost
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Nov 2018
- Primary completion9 Aug 2020
- Study completion9 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 full factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729479
- Sponsor's protocol ID
- HUM00146610
- Status last verified
- Sep 2020
- First submitted
- 31 Oct 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saslow LR, Jones LM, Sen A, Wolfson JA, Diez HL, O'Brien A, Leung CW, Bayandorian H, Daubenmier J, Missel AL, Richardson C. Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial. Ann Fam Med. 2023 May-Jun;21(3):256-263. doi: 10.1370/afm.2968.
PubMed 37217318
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MHERO Study (Michigan's Hypertension, Diabetes, and Obesity Education Research Online)
- ClinicalTrials.gov ID
- NCT03729479
- Acronym / sponsor ID
- HUM00146610
- Keywords
- dietary intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 9 Aug 2020 (actual)
- Study completion
- 9 Aug 2020 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 full factorial
| Arm | Type | Receives |
|---|---|---|
| Experimental: DASH diet | Experimental | Behavioral: DASH dietParticipants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted). |
| Experimental: very low carbohydrate, ketogenic diet | Experimental | Behavioral: Very low carbohydrate, ketogenic dietParticipants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted). |
| Experimental: DASH diet and extra support | Experimental | Behavioral: DASH diet, Behavioral: ExtrasParticipants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. |
| Experimental: very low carb, ketogenic diet and extra support | Experimental | Behavioral: Very low carbohydrate, ketogenic diet, Behavioral: ExtrasParticipants will be taught to follow a very low-carbohydrate, ketogenic diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted). They will also be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Aged 21-70 years old
- Access to the internet and text messaging
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH dietParticipants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted). | Behavioural | Experimental: DASH diet, Experimental: DASH diet and extra support |
| Very low carbohydrate, ketogenic dietParticipants will be taught to follow a very low-carbohydrate diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted). | Behavioural | Experimental: very low carb, ketogenic diet and extra support, Experimental: very low carbohydrate, ketogenic diet |
| ExtrasParticipants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior. | Behavioural | Experimental: DASH diet and extra support, Experimental: very low carb, ketogenic diet and extra support |
Primary outcome
Systolic blood pressure
Time frame: 4 months
Measured with sphygmomanometer, assessed as change in blood pressure (systolic and diastolic blood pressure will both be measured, but systolic blood pressure is the main outcome)
2 secondary outcomes
Glycemic control
Time frame: 4 months
Weight loss
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 37217318Saslow LR, Jones LM, Sen A, Wolfson JA, Diez HL, O'Brien A, Leung CW, Bayandorian H, Daubenmier J, Missel AL, Richardson C. Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial. Ann Fam Med. 2023 May-Jun;21(3):256-263. doi: 10.1370/afm.2968.
- Individual participant dataSharing planned: No
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DASH diet, Very low carbohydrate, ketogenic diet and Extras in people with Type2 Diabetes Mellitus and Hypertension, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03729479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.