Dietary Intervention in Type-2 Diabetes and Pre-Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Metabolic Syndrome
- Pre Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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 single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group) Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02519309
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sarah Hallberg, DO, MS Indiana University Health
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