Clinical trial NCT02519309: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Pre-diabetes
Metabolic Syndrome
Lead sponsor: Virta Health
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 465
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Type-2 Diabetes Status
timeFrame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
measure: Change from Baseline Metabolic Syndrome Status
timeFrame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
measure: Change from Baseline Body Weight
timeFrame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Secondary outcomes:
measure: Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
timeFrame: 12 and 24 Months
measure: Change from Baseline Serum Lipids
timeFrame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
measure: Change from Baseline Body Composition
timeFrame: 3,12 and 24 Months (intervention arms only)
measure: Change from Baseline Type-2 Diabetes Status
timeFrame: 42 and 60 Months (intervention arms only)
measure: Change from Baseline Metabolic Syndrome Status
timeFrame: 42 and 60 Months (intervention arms only)
measure: Change from Baseline Body Weight
timeFrame: 42 and 60 Months (intervention arms only)
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: IU Health Arnett Medical Weight Loss
state: Indiana
Study officials:
affiliation: Indiana University Health
name: Sarah Hallberg, DO, MS
role: PRINCIPAL_INVESTIGATOR
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