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Completed

NCT Number: NCT02519309

Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pre-diabetes

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Arnett Medical Weight Loss

West Lafayette, Indiana, 47904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virta Program

Other

Primary outcomes

  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 outcomes

  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 including lipoprotein 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

Sponsors and collaborators

Lead sponsor

Virta Health

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Aug 10, 2015
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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