xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986097</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00225646</org_study_id>
      <nct_id>NCT05986097</nct_id>
    </id_info>
    <brief_title>The Breakfast Study</brief_title>
    <official_title>The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial&#xD;
        of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type&#xD;
        2 diabetes. The investigators will measure acceptability and feasibility, plus critical&#xD;
        efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic&#xD;
        variability, body weight, blood pressure, and lipids.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood gluocse, here&#xD;
        defined as a glycated hemoglobin (HbA1c) level of 8.0% or higher. These adults have an&#xD;
        elevated health risk of a variety of outcomes, including amputation and mortality from&#xD;
        cardiovascular disease and from all causes. Nutrition- focused interventions can be effective&#xD;
        for improving glycemic control, reducing anti-hyperglycemic medications, and reducing body&#xD;
        weight, all of which are critical outcomes for adults with type 2 diabetes. However, typical&#xD;
        nutrition-focused interventions can be burdensome, often requiring complex instructions and a&#xD;
        complete overhaul of one's diet. Additionally, adults with poorly controlled type 2 diabetes&#xD;
        are more likely to have low literacy levels, which can be a barrier for adherence to complex&#xD;
        interventions. Therefore, an effective intervention for adults with poorly controlled&#xD;
        diabetes who may have lower health literacy levels is necessary to reduce both HbA1c levels&#xD;
        and anti-hyperglycemic medications. Carbohydrate intake has the strongest impact on&#xD;
        post-prandial glycemia of any dietary factor, and a very low-carbohydrate diet-due to its&#xD;
        ability to improve glycemic control-is now recommended by the American Diabetes Association&#xD;
        (ADA) for the treatment of type 2 diabetes. The investigators hypothesize that some of the&#xD;
        benefits of a very low-carbohydrate diet may be available to individuals who change only&#xD;
        their breakfasts to be very low-carbohydrate, rather than modifying their entire diet.&#xD;
  &#xD;
        Thus, the investigators will conduct an acceptability, feasibility, preliminary effectiveness&#xD;
        trial of a 4-month, online, small- steps, low-literacy, very low-carbohydrate&#xD;
        breakfast-focused program in 120 adults with poorly controlled type 2 diabetes. The&#xD;
        investigators will measure acceptability and feasibility, plus critical efficacy outcomes,&#xD;
        such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight,&#xD;
        blood pressure, and lipids.&#xD;
  &#xD;
        The investigators will also test whether factors such as sex, health literacy level, and&#xD;
        baseline insulin resistance significantly moderate the impact of the intervention on change&#xD;
        in HbA1c and change in anti-hyperglycemic medications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>All participants will be provided the same intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Blood tests and continuous glucose monitoring are masked.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c change</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>percentage of glycosylated hemoglobin</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in glycemic variability</measure>
      <time_frame>0-4 months</time_frame>
      <description>This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants' upper arm and the information on the sensor is blinded to participants.&#xD;
  The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point.&#xD;
  The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in percent body weight loss</measure>
      <time_frame>0-4 months</time_frame>
      <description>percent change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)</measure>
      <time_frame>0-4 months</time_frame>
      <description>High-sensitivity C-reactive protein will be measured with nephelometric methods utilizing latex particles coated with CRP monoclonal antibodies and standardized against a CRP reference preparation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in low-density lipoproteins (LDL)</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>This will assess the change in the level reported for this outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in high-density lipoproteins (HDL)</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>This will assess the change in the level reported for this outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in triglycerides</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>This will assess the change in the level reported for this outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in systolic blood pressure</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>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 of interest)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in insulin resistance</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>At baseline and 4 months, we will use fasting insulin and glucose to estimate insulin resistance by calculating Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Very low-carbohydrate breakfast</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Materials will encourage eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Breakfast</intervention_name>
      <description>We will provide participants recipes and information to support this dietary change.</description>
      <arm_group_label>Very low-carbohydrate breakfast</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HbA1c 8% or higher&#xD;
  &#xD;
            -  18-80 years old&#xD;
  &#xD;
            -  The ability to understand verbal and written English&#xD;
  &#xD;
            -  Willingness to follow the prescribed diet&#xD;
  &#xD;
            -  Able to consent and follow directions&#xD;
  &#xD;
            -  Willingness to regularly check blood glucose levels as required&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to provide informed consent&#xD;
  &#xD;
            -  Pregnant, breastfeeding, or planning for either in the next 6 months or &lt;6 months&#xD;
               postpartum&#xD;
  &#xD;
            -  Low C-peptide and possible subsequent GAD 65 level that suggests type 1 diabetes,&#xD;
               clinical factors that suggest type 1 diabetes (lean, lack of family history, and&#xD;
               diabetic ketoacidosis in the past) or a previous diagnosis of type 1 diabetes or&#xD;
               latent autoimmune diabetes&#xD;
  &#xD;
            -  Cancer, heart failure, or kidney failure&#xD;
  &#xD;
            -  Vegan&#xD;
  &#xD;
            -  Untreated mental health condition&#xD;
  &#xD;
            -  Currently following a very low-carbohydrate diet or breakfasts&#xD;
  &#xD;
            -  Thyroid levels out of range&#xD;
  &#xD;
            -  Alcoholism&#xD;
  &#xD;
            -  Previous bariatric surgery&#xD;
  &#xD;
            -  Difficulty chewing or swallowing&#xD;
  &#xD;
            -  Dependence on others for food preparation&#xD;
  &#xD;
            -  Currently enrolled in another investigative study that might conflict with this&#xD;
               research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Laura Saslow, PhD</last_name>
        <phone>734-763-4995</phone>
        <email>breakfaststudy@med.umich.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Laura Saslow</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Very low carbohydrate diet</keyword>
    <keyword>Nutrition therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986097
  org study id: HUM00225646
  nct id: NCT05986097
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial
        of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type
        2 diabetes. The investigators will measure acceptability and feasibility, plus critical
        efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic
        variability, body weight, blood pressure, and lipids.
  More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood gluocse, here
        defined as a glycated hemoglobin (HbA1c) level of 8.0% or higher. These adults have an
        elevated health risk of a variety of outcomes, including amputation and mortality from
        cardiovascular disease and from all causes. Nutrition- focused interventions can be effective
        for improving glycemic control, reducing anti-hyperglycemic medications, and reducing body
        weight, all of which are critical outcomes for adults with type 2 diabetes. However, typical
        nutrition-focused interventions can be burdensome, often requiring complex instructions and a
        complete overhaul of one's diet. Additionally, adults with poorly controlled type 2 diabetes
        are more likely to have low literacy levels, which can be a barrier for adherence to complex
        interventions. Therefore, an effective intervention for adults with poorly controlled
        diabetes who may have lower health literacy levels is necessary to reduce both HbA1c levels
        and anti-hyperglycemic medications. Carbohydrate intake has the strongest impact on
        post-prandial glycemia of any dietary factor, and a very low-carbohydrate diet-due to its
        ability to improve glycemic control-is now recommended by the American Diabetes Association
        (ADA) for the treatment of type 2 diabetes. The investigators hypothesize that some of the
        benefits of a very low-carbohydrate diet may be available to individuals who change only
        their breakfasts to be very low-carbohydrate, rather than modifying their entire diet.
  
        Thus, the investigators will conduct an acceptability, feasibility, preliminary effectiveness
        trial of a 4-month, online, small- steps, low-literacy, very low-carbohydrate
        breakfast-focused program in 120 adults with poorly controlled type 2 diabetes. The
        investigators will measure acceptability and feasibility, plus critical efficacy outcomes,
        such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight,
        blood pressure, and lipids.
  
        The investigators will also test whether factors such as sex, health literacy level, and
        baseline insulin resistance significantly moderate the impact of the intervention on change
        in HbA1c and change in anti-hyperglycemic medications.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All participants will be provided the same intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Blood tests and continuous glucose monitoring are masked.
  measure: HbA1c change
  time frame: 0 to 4 months
  description: percentage of glycosylated hemoglobin
  measure: Change in glycemic variability
  time frame: 0-4 months
  description: This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants' upper arm and the information on the sensor is blinded to participants.
  The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point.
  The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations.
  measure: Change in percent body weight loss
  time frame: 0-4 months
  description: percent change
  measure: Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)
  time frame: 0-4 months
  description: High-sensitivity C-reactive protein will be measured with nephelometric methods utilizing latex particles coated with CRP monoclonal antibodies and standardized against a CRP reference preparation.
  measure: Change in low-density lipoproteins (LDL)
  time frame: 0 to 4 months
  description: This will assess the change in the level reported for this outcome
  measure: Change in high-density lipoproteins (HDL)
  time frame: 0 to 4 months
  description: This will assess the change in the level reported for this outcome
  measure: Change in triglycerides
  time frame: 0 to 4 months
  description: This will assess the change in the level reported for this outcome
  measure: Change in systolic blood pressure
  time frame: 0 to 4 months
  description: 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 of interest)
  measure: Change in insulin resistance
  time frame: 0 to 4 months
  description: At baseline and 4 months, we will use fasting insulin and glucose to estimate insulin resistance by calculating Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
  arm group label: Very low-carbohydrate breakfast
  arm group type: Experimental
  description: Materials will encourage eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each.
  intervention type: Behavioral
  intervention name: Breakfast
  description: We will provide participants recipes and information to support this dietary change.
  arm group label: Very low-carbohydrate breakfast
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Laura Saslow
  investigator title: Associate Professor
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No