Dietary Intervention in Type-2 Diabetes and Pre-Diabetes
NCT ID: NCT02519309
Last Updated: 2022-04-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
465 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-08-31
Study Completion Date
2021-04-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Diabetes Mellitus, Type 2
Pre-diabetes
Metabolic Syndrome
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
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)
2. single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Virta Program
Intervention Type
OTHER
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.
Group Type
EXPERIMENTAL
Virta Program
Intervention Type
OTHER
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Virta Program
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
21 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Virta Health
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sarah Hallberg, DO, MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University Health
Locations
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IU Health Arnett Medical Weight Loss
West Lafayette, Indiana, United States
Site Status
Countries
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United States
References
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Lyman KS, Athinarayanan SJ, McKenzie AL, Pearson CL, Adams RN, Hallberg SJ, McCarter JP, Volek JS, Phinney SD, Andrawis JP. Continuous care intervention with carbohydrate restriction improves physical function of the knees among patients with type 2 diabetes: a non-randomized study. BMC Musculoskelet Disord. 2022 Mar 29;23(1):297. doi: 10.1186/s12891-022-05258-0.
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Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.
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Vilar-Gomez E, Athinarayanan SJ, Adams RN, Hallberg SJ, Bhanpuri NH, McKenzie AL, Campbell WW, McCarter JP, Phinney SD, Volek JS, Chalasani N. Post hoc analyses of surrogate markers of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis in patients with type 2 diabetes in a digitally supported continuous care intervention: an open-label, non-randomised controlled study. BMJ Open. 2019 Feb 25;9(2):e023597. doi: 10.1136/bmjopen-2018-023597.
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Bhanpuri NH, Hallberg SJ, Williams PT, McKenzie AL, Ballard KD, Campbell WW, McCarter JP, Phinney SD, Volek JS. Cardiovascular disease risk factor responses to a type 2 diabetes care model including nutritional ketosis induced by sustained carbohydrate restriction at 1 year: an open label, non-randomized, controlled study. Cardiovasc Diabetol. 2018 May 1;17(1):56. doi: 10.1186/s12933-018-0698-8.
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Hallberg SJ, McKenzie AL, Williams PT, Bhanpuri NH, Peters AL, Campbell WW, Hazbun TL, Volk BM, McCarter JP, Phinney SD, Volek JS. Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. Diabetes Ther. 2018 Apr;9(2):583-612. doi: 10.1007/s13300-018-0373-9. Epub 2018 Feb 7.
Reference Type
DERIVED
Other Identifiers
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2015-1
Identifier Type: -
Identifier Source: org_study_id
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