NCT02609243

Diabetes Nutrition Algorithm - Prediabetes

Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: German Institute of Human Nutrition · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.

Detailed description

Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement. The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design. Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.

Conditions

• Prediabetes
• Diabetes Mellitus Type 2
• Obesity
• NAFLD
• Dyslipoproteinemia

Interventions

Type	Name	Description
BEHAVIORAL	dietary consulting	dietary consulting implies specific dietary advice based on pre-interventional self-report regarding food intake; consulting focuses on nutrient content, calory intake, weight loss; with regard to randomisation consulting intensity and content varies

Timeline

• Start date: 2013-07-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2015-11-20
• Last updated: 2020-06-24

Locations

2 sites across 1 country: Germany