Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

April 25, 2022 updated by: Virta Health

Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47904
        • IU Health Arnett Medical Weight Loss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
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 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
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
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 and 24 Months
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
3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
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
3,12 and 24 Months (intervention arms only)
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)
42 and 60 Months (intervention arms only)
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
42 and 60 Months (intervention arms only)
Change from Baseline Body Weight
Time Frame: 42 and 60 Months (intervention arms only)
Body weight will be evaluated on a calibrated scale
42 and 60 Months (intervention arms only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virta Health

Investigators

  • Principal Investigator: Sarah Hallberg, DO, MS, Indiana University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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