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Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

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ClinicalTrials.gov Identifier: NCT02519309
Recruitment Status : Active, not recruiting
First Posted : August 10, 2015
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Virta Health

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Pre-diabetes Metabolic Syndrome Other: Virta Program Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Official Title: Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake
Study Start Date : August 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
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.
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.
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.



Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Change from Baseline Serum Lipids [ Time Frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) ]
    Serum lipids analyzed by NMR to determine LDL particle size and number

  3. 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

  4. 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)

  5. 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

  6. Change from Baseline Body Weight [ Time Frame: 42 and 60 Months (intervention arms only) ]
    Body weight will be evaluated on a calibrated scale



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519309


Locations
United States, Indiana
IU Health Arnett Medical Weight Loss
West Lafayette, Indiana, United States, 47904
Sponsors and Collaborators
Virta Health
Investigators
Principal Investigator: Sarah Hallberg, DO, MS Indiana University Health

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virta Health
ClinicalTrials.gov Identifier: NCT02519309     History of Changes
Other Study ID Numbers: 2015-1
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Hyperglycemia