Effect of Diet and Physical Activity on Incidence of Type 2 Diabetes

Summary

Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been initiated to find out the most effective lifestyle-components (diet and physical activity) in the prevention of Type-2 diabetes. The project consists of a randomized lifestyle-intervention with the more specific aim to determine the preventative impact of a high-protein and low-GI diet in combination with moderate or high intensity physical activity compared with a moderate-protein and moderate GI diet in combination with the same activity levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children, young and older adults.

The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain, Netherlands, UK) and Australia and New Zealand.

A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children and adolescents aged 10-18 y) will be recruited. All adult participants are first treated by a low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and adolescents are treated separately with a conventional weight-reduction diet, with-out a specific aim for absolute weight loss.

The adult participants are randomized into two different diet interventions and two exercise interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by weight-maintenance (prevention of relapse in reduced body weight) and by independent metabolic effects of diet and physical activity.

The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3 years (156 weeks) according to diet (high protein/low-GI versus moderate protein/moderate-GI, adjusted for physical activity), based on a 75 g oral glucose tolerance test and/or HbA1c.

For children and adolescents:

Change in insulin resistance at 2 years after randomization to high protein versus moderate protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as well as physiological improvement of health with respect to pre-diabetic characteristics.

Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2 diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity physical activity will be superior compared to moderate-intensity physical activity.

Conditions

• Pre-diabetes
• Obesity

Interventions

BEHAVIORAL

High protein/ high intensity physical activity (HP-HI)

Participants follow a high protein diet and a high intensity physical activity intervention

BEHAVIORAL

High protein / moderate intensity physical activity (HP-MI)

Participants follow a high protein diet and moderate intensity physical activity intervention

BEHAVIORAL

Moderate protein/ high intensity physical activity (MP-HI)

Participants follow a moderate protein diet and a high intensity physical activity intervention

BEHAVIORAL

Moderate protein/ moderate intensity physical activity (MP-MI)

Participants follow a moderate protein diet and moderate intensity physical activity intervention

Sponsors & Collaborators

• University of Helsinki

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• University of Navarra

  collaborator OTHER

• Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• University of Auckland, New Zealand

  collaborator OTHER

• University of Stuttgart

  collaborator OTHER

• Swansea University

  collaborator OTHER

• Cambridge Manufacturing Company Limited

  collaborator INDUSTRY

• European Union

  collaborator OTHER

• Wageningen University

  collaborator OTHER

• Meyers Madhus

  collaborator UNKNOWN

• NetUnion SARL

  collaborator UNKNOWN

• Terveyden Ja Hyvinvoinnin Laitos

  collaborator UNKNOWN

• Laval University

  collaborator OTHER

• Anne Birgitte Raben

  lead OTHER

Principal Investigators

• Thomas M Larsen, Ass. Prof. · University of Copenhagen

• Mikael Fogelholm, Professor · University of Helsinki

• Margriet Westerterp-Plantenga, Professor · Maastricht University

• Ian Macdonald, Professor · University of Nottingham Medical School

• J. Alfredo Martinez, Professor · University of Navarra

• Svetoslav Handjiev, Professor · Medical University Sofia

• Jennie Brand-Miller, Professor · University of Sydney

• Sally D. Poppitt, Professor · University of Auckland, New Zealand

• Gareth Stratton, Professor · Swansea University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2018-03-31

Completion

2018-12-31

Countries

• Australia
• Bulgaria
• Denmark
• Finland
• Netherlands
• New Zealand
• Spain
• United Kingdom

Study Locations