Diabetes Nutrition Algorithm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Individualized Lifestyle Intervention in Subjects With Prediabetes

NCT01947595

Diabetes Mellitus Type 2

COMPLETED NA

A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support

NCT00677937

Type 2 Diabetes Mellitus

COMPLETED NA

Computer-assisted Diabetes Self-management Interventions

NCT00006163

Diabetes Mellitus, Type 2

COMPLETED PHASE4

Personalized Dietary Management in Type 2 Diabetes

NCT05046886

Type 2 Diabetes

ACTIVE_NOT_RECRUITING NA

Family-based Prevention of Diabetes Through Eating Habits and Physical Activity

NCT05694351

Diabetes Mellitus, Type 2 Family Health Health Behavior +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Prediabetes Diabetes Mellitus Type 2 Obesity NAFLD Dyslipoproteinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intensive consulting, conventional diet

subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat ) - dietary intervention without supplement

Group Type ACTIVE_COMPARATOR