Back to resultsDietary Intervention in Type-2 Diabetes and Pre-Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Pre-diabetes, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virta Program
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- IU Health Arnett Medical Weight Loss
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
onsite
web-based
Control (usual care)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Change from Baseline Metabolic Syndrome Status
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
Body weight will be evaluated on a calibrated scale
Secondary Outcome Measures
Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
Ultrasound Measurement of the Carotid Artery
Change from Baseline Serum Lipids
Serum lipids including lipoprotein size and number
Change from Baseline Body Composition
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
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Change from Baseline Metabolic Syndrome Status
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
Body weight will be evaluated on a calibrated scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02519309
Brief Title
Dietary Intervention in Type-2 Diabetes and Pre-Diabetes
Official Title
Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virta Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Pre-diabetes, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
465 (Actual)
8. Arms, Groups, and Interventions
Arm Title
onsite
Arm Type
Experimental
Arm Description
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.
Arm Title
web-based
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (usual care)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virta Program
Primary Outcome Measure Information:
Title
Change from Baseline Type-2 Diabetes Status
Description
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Time Frame
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Title
Change from Baseline Metabolic Syndrome Status
Description
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
Time Frame
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Title
Change from Baseline Body Weight
Description
Body weight will be evaluated on a calibrated scale
Time Frame
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Secondary Outcome Measure Information:
Title
Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
Description
Ultrasound Measurement of the Carotid Artery
Time Frame
12 and 24 Months
Title
Change from Baseline Serum Lipids
Description
Serum lipids including lipoprotein size and number
Time Frame
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Title
Change from Baseline Body Composition
Description
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
Time Frame
3,12 and 24 Months (intervention arms only)
Title
Change from Baseline Type-2 Diabetes Status
Description
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Time Frame
42 and 60 Months (intervention arms only)
Title
Change from Baseline Metabolic Syndrome Status
Description
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
Time Frame
42 and 60 Months (intervention arms only)
Title
Change from Baseline Body Weight
Description
Body weight will be evaluated on a calibrated scale
Time Frame
42 and 60 Months (intervention arms only)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Hallberg, DO, MS
Organizational Affiliation
Indiana University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health Arnett Medical Weight Loss
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
12. IPD Sharing Statement
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Dietary Intervention in Type-2 Diabetes and Pre-Diabetes
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