Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

NCT02519309 | Completed

• 1 other identifier: 2015-1
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Pre-diabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Type-2 Diabetes Status

  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

  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

  Body weight will be evaluated on a calibrated scale

  3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)

Secondary Outcomes (6)

• Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)

  12 and 24 Months

• Change from Baseline Serum Lipids

  3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)

• Change from Baseline Body Composition

  3,12 and 24 Months (intervention arms only)

• Change from Baseline Type-2 Diabetes Status

  42 and 60 Months (intervention arms only)

• Change from Baseline Metabolic Syndrome Status

  42 and 60 Months (intervention arms only)

Study Arms (3)

onsite

EXPERIMENTAL

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

web-based

EXPERIMENTAL

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

Control (usual care)

NO INTERVENTION

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.

Interventions

Virta Program OTHER

onsite; web-based

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virta Health: lead

Study Sites (1)

IU Health Arnett Medical Weight Loss

West Lafayette, Indiana, 47904, United States

Location

Related Publications (30)

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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.

  PMID: 29417495 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Insulin Resistance; Hyperinsulinism

Study Officials

• Sarah Hallberg, DO, MS

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 10, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2021
• Last Updated: April 27, 2022

Record last verified: 2020-07

Locations

US (1)