NCT02519309

Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Virta Health · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Virta Program

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-04-01
• Completion: 2021-04-01
• First posted: 2015-08-10
• Last updated: 2022-04-27

Locations

1 site across 1 country: United States