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Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519309
Recruitment Status : Active, not recruiting
First Posted : August 10, 2015
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Virta Health

Tracking Information
First Submitted Date  ICMJE August 4, 2015
First Posted Date  ICMJE August 10, 2015
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Change from Baseline Type-2 Diabetes Status [ Time Frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) ]
    Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
  • Change from Baseline Metabolic Syndrome Status [ Time Frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) ]
    Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following:
    • Waist circumference: ≥40 inches (men) or ≥35 inches (women)
    • Fasting triglycerides: ≥150 mg/dL
    • HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
    • Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
    • Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
  • Change from Baseline Body Weight [ Time Frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) ]
    Body weight will be evaluated on a calibrated scale
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
  • Change from Baseline Body Weight at 3 months [ Time Frame: 3 Months ]
    Body weight will be evaluated on a calibrated scale
  • Change from Baseline Body Weight at 12 months [ Time Frame: 12 Months ]
    Body weight will be evaluated on a calibrated scale
  • Change from Baseline Body Weight at 24 months [ Time Frame: 24 Months ]
    Body weight will be evaluated on a calibrated scale
  • Change from Baseline Metabolic Syndrome Status at 3 Months [ Time Frame: 3 Months ]
    Metabolic syndrome status will be evaluated by determining standard markers. Metabolic syndrome is defined as having at least three of the following:
    • Waist circumference: ≥40 inches (men) or ≥35 inches (women)
    • Fasting triglycerides: ≥150 mg/dL
    • HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
    • Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
    • Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
  • Change from Baseline Metabolic Syndrome Status at 12 Months [ Time Frame: 12 Months ]
    Metabolic syndrome status will be evaluated by determining standard markers. Metabolic syndrome is defined as having at least three of the following:
    • Waist circumference: ≥40 inches (men) or ≥35 inches (women)
    • Fasting triglycerides: ≥150 mg/dL
    • HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
    • Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
    • Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
  • Change from Baseline Metabolic Syndrome Status at 24 Months [ Time Frame: 24 Months ]
    Metabolic syndrome status will be evaluated by determining standard markers. Metabolic syndrome is defined as having at least three of the following:
    • Waist circumference: ≥40 inches (men) or ≥35 inches (women)
    • Fasting triglycerides: ≥150 mg/dL
    • HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
    • Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
    • Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
  • Change from Baseline Type-2 Diabetes Status at 3 Months [ Time Frame: 3 Months ]
    Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c), an important indicator that reflects average blood glucose levels over the past three months.
  • Change from Baseline Type-2 Diabetes Status at 12 Months [ Time Frame: 12 Months ]
    Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c), an important indicator that reflects average blood glucose levels over the past three months.
  • Change from Baseline Type-2 Diabetes Status at 24 Months [ Time Frame: 24 Months ]
    Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c), an important indicator that reflects average blood glucose levels over the past three months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only) [ Time Frame: 12 and 24 Months ]
    Ultrasound Measurement of the Carotid Artery
  • Change from Baseline Serum Lipids [ Time Frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) ]
    Serum lipids including lipoprotein size and number
  • Change from Baseline Body Composition [ Time Frame: 3,12 and 24 Months (intervention arms only) ]
    Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
  • Change from Baseline Type-2 Diabetes Status [ Time Frame: 42 and 60 Months (intervention arms only) ]
    Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
  • Change from Baseline Metabolic Syndrome Status [ Time Frame: 42 and 60 Months (intervention arms only) ]
    Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following:
    • Waist circumference: ≥40 inches (men) or ≥35 inches (women)
    • Fasting triglycerides: ≥150 mg/dL
    • HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
    • Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
    • Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
  • Change from Baseline Body Weight [ Time Frame: 42 and 60 Months (intervention arms only) ]
    Body weight will be evaluated on a calibrated scale
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
  • Change from Baseline Carotid Intima Media Thickness (CIMT) at 12 Months [ Time Frame: 12 Months ]
    Ultrasound Measurement of the Carotid Artery
  • Change from Baseline Carotid Intima Media Thickness (CIMT) at 24 Months [ Time Frame: 24 Months ]
    Ultrasound Measurement of the Carotid Artery
  • Change from Baseline Serum Lipids at 3 Months [ Time Frame: 3 Months ]
    Serum lipids analyzed by NMR to determine LDL particle size and number
  • Change from Baseline Serum Lipids at 12 Months [ Time Frame: 12 Months ]
    Serum lipids analyzed by NMR to determine LDL particle size and number
  • Change from Baseline Serum Lipids at 24 Months [ Time Frame: 24 Months ]
    Serum lipids analyzed by NMR to determine LDL particle size and number
  • Change from Baseline Body Composition at 3 Months [ Time Frame: 3 Months ]
    Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
  • Change from Baseline Body Composition at 12 Months [ Time Frame: 12 Months ]
    Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
  • Change from Baseline Body Composition at 24 Months [ Time Frame: 24 Months ]
    Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Intervention in Type-2 Diabetes and Pre-Diabetes
Official Title  ICMJE Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake
Brief Summary The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.
Detailed Description

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.

Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. open label, non-randomized, before-and-after study of patients with type 2 diabetes who self-select the intervention (with education delivered via onsite group classes or web-based, self-selected by participant) or usual care
  2. single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Pre-diabetes
  • Metabolic Syndrome
Intervention  ICMJE Other: Virta Program
Study Arms  ICMJE
  • Experimental: onsite
    Education (the virta program) for the onsite group will be delivered in person, with 26 classes over 12 months including group and individual sessions. Sessions will be scheduled weekly for the first 3 months, biweekly during months 4-6, and monthly thereafter. Each session will last approximately 90 minutes.
    Intervention: Other: Virta Program
  • Experimental: web-based
    Education (the virta program) for the web-based educational group will be the same content as the onsite group, but delivered via the web and completed at the participant's own pace.
    Intervention: Other: Virta Program
  • No Intervention: Control (usual care)
    The study will make no intervention to this group. Participants in this group will be recent referrals to a local diabetes education program and care for their condition will continue to be managed by their own medical providers.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2015)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Body weight/Diabetes:

  • Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure)
  • Fasting glucose >126 mg/dL or HbA1c >6.5

Body weight/ Pre-diabetes:

• Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects)

Ethnicity: all ethnic groups

Exclusion Criteria:

  • BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome
  • Type 1 diabetes
  • History of keto-acidosis
  • History of MI, stroke, angina, coronary insufficiency within the last 6 months
  • Diabetic retinopathy requiring treatment
  • Creatinine > 2.0
  • Urinary albumin > 1 g/d
  • Impaired hepatic function (Bilirubin >2, Albumin < 3.5)
  • Cholelithiasis or biliary dysfunction
  • Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer
  • Chronic infectious disease requiring ongoing treatment
  • Other chronic diseases or condition likely to limit lifespan to <6 years
  • Non-English speaking
  • Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions)
  • Weight loss of >10% in past 6 months
  • Currently pregnant or nursing, or planning to become pregnant during the study
  • Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled
  • Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02519309
Other Study ID Numbers  ICMJE 2015-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virta Health
Study Sponsor  ICMJE Virta Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah Hallberg, DO, MS Indiana University Health
PRS Account Virta Health
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP