Effect of Diet and Physical Activity on Incidence of Type 2 Diabetes (PREVIEW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Copenhagen
Sponsor:
Collaborators:
Helsinki University
Maastricht University
University of Nottingham
University of Navarra
Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria
University of Sydney
University of Auckland, New Zealand
University of Stuttgart
Swansea University
Cambridge Manufacturing Company Limited
European Union
Information provided by (Responsible Party):
Anne Birgitte Raben, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01777893
First received: January 24, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 initialized to find the most effective lifestyle-components (diet and physical activity) to prevent 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 participants (200 children and adolescents aged 10—18 y, 800 younger adults, aged 25—45 y, and 1,500 older adults, aged 55—70 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.

Before the weight reduction, the 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 3 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.


Condition Intervention
Pre-diabetes
Obesity
Behavioral: High protein/ high intensity physical activity (HP-HI)
Behavioral: High protein / moderate intensity physical activity (HP-MI)
Behavioral: Moderate protein/ high intensity physical activity (MP-HI)
Behavioral: Moderate protein/ moderate intensity physical activity (MP-MI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PREVention of Diabetes Through Lifestyle Intervention and Population Studies in Europe and Around the World

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Incidence of type 2 diabetes [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    For adults:

    Incidence of type 2 diabetes, in high protein versus medium protein diet, measured during 3 years after baseline and based on WHO/IDF criteria:

    Fasting plasma glucose (FPG) > 7.0 mmol/l (126 mg/dl) or, 75 g oral glucose tolerance test (OGTT) with FPG > 7.0 mmol/l (126 mg/dl) and/or 2 hour plasma glucose > 11.1 mmol/l (200 mg/dl) or, Glycated haemoglobin (HbA1c) > 6.5% (48 mmol/mol), or Random plasma glucose > 11.1 mmol/l (200 mg/dl) in the presence of classical diabetes symptoms.

    For children and adolescents:

    Change in insulin resistance at 3 years after randomization to high protein versus medium protein diet, measured by insulin resistance analysed by the homeostatic model (HOMA-IR).



Secondary Outcome Measures:
  • Incidence of type-2 diabetes [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    For adults:

    The effect of high intensity vs. moderate intensity physical activity on incidence of type 2 diabetes, based on WHO/IDF criteria (adjusted for diet).

    Fasting plasma glucose (FPG) > 7.0 mmol/l (126 mg/dl) or, 75 g oral glucose tolerance test (OGTT) with FPG > 7.0 mmol/l (126 mg/dl) and/or 2 hour plasma glucose > 11.1 mmol/l (200 mg/dl) or, Glycated hemoglobin (HbA1c) > 6.5% (48 mmol/mol), or Random plasma glucose > 11.1 mmol/l (200 mg/dl) in the presence of classical diabetes symptoms.

    For children and adolescents:

    Change in insulin resistance at 3 years after randomization to high intensity vs. moderate intensity physical activity, analyzed by the homeostatic model (HOMA-IR).


  • Change in HbA1c, a measure of average blood glucose levels [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in body weight and waist, hip and thigh circumference [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in body fat mass (kg, proportion of body weight) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Proportion of subjects maintaining at least 0, 5 or 10% weight loss (relative to initial body weight) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Risk factors for cardiovascular disease, with at least the following measures: blood pressure, lipids (triglycerides, total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol), C-reactive protein, and liver enzymes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in perceived quality of life and workability, habitual well-being, sleep and chronic stress, subjective appetite sensations, and habitual physical activity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HP-HI
High protein/ high intensity physical activity
Behavioral: High protein/ high intensity physical activity (HP-HI)
Participants follow a high protein diet and a high intensity physical activity intervention
Active Comparator: HP-MI
High protein/ moderate intensity physical activity
Behavioral: High protein / moderate intensity physical activity (HP-MI)
Participants follow a high protein diet and moderate intensity physical activity intervention
Active Comparator: MP-HI
Moderate protein/ high intensity physical activity
Behavioral: Moderate protein/ high intensity physical activity (MP-HI)
Participants follow a moderate protein diet and a high intensity physical activity intervention
Active Comparator: MP-MI
Moderate protein/ moderate intensity physical activity
Behavioral: Moderate protein/ moderate intensity physical activity (MP-MI)
Participants follow a moderate protein diet and moderate intensity physical activity intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For adults:

  1. Age 25 - 45 years and 55 - 70 years
  2. Overweight or obesity status BMI>25 kg/m2
  3. Pre-diabetes The criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having:

    Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 - 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l.

    Due to potential between-lab variation (local assessments), HbA1c is not used as an inclusion criteria in the screening.

  4. Informed consent required
  5. Ethnic group - No restrictions
  6. Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
  7. Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol
  8. Other - Able to participate at CID's during normal working hours.

For children and adolescents:

  1. Age 10-18 years
  2. Age-adjusted value corresponding to BMI>25 kg/m2 (Cole et al. 2000)
  3. Since the prevalence of pre-diabetes among children with overweight or obesity is low, it is not feasible to include exclusively pre-diabetic children (according to criteria of the IDF).

    Therefore insulin resistant over-weight/obese children will be included, defined as: HOMA-IR >2

  4. Informed consent required
  5. Ethnic group - No restrictions
  6. Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
  7. Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol
  8. Other - Able to participate at CID's during normal school/working hours.

Exclusion Criteria:

Based on interview and/or questionnaire, individuals with the following problems will be excluded:

Medical conditions as known by the subjects:

  1. Diabetes mellitus (other than gestational diabetes mellitus);
  2. Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease ;
  3. Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months;
  4. Advanced chronic renal impairment;
  5. Significant liver disease e.g. cirrhosis (fatty liver disease allowed);
  6. Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed);
  7. Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption;
  8. Previous bariatric surgery;
  9. Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program);
  10. A recent surgical procedure until after full convalescence (investigators judgement);
  11. Transmissible blood-borne diseases e.g. hepatitis B, HIV;
  12. Psychiatric illness (e.g. major depression, bipolar disorder).

    Medication:

  13. Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.

    Personal/Other:

  14. Engagement in competitive sports;
  15. Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening;
  16. Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed;
  17. Severe food intolerance expected to interfere with the study;
  18. Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women);
  19. Use of drugs of abuse within the previous 12 months;
  20. Blood donation or transfusion within the past 1 month before baseline or CID's;
  21. Self-reported eating disorders;
  22. Pregnancy or lactation, including plans to become pregnant within the next 36 months.
  23. No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase);
  24. Adequate understanding of national language;
  25. Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol.

    Laboratory screening:

    If all of the above criteria are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation.

    ONLY IF the glucose tolerance test meets the entry criteria for the study, the remaining samples are sent to the local laboratory for a safety check, with the following exclusion criteria:

  26. Hemoglobin concentration below local laboratory reference values (i.e. anemia).
  27. Creatinine >1.5 times Upper Limit of Normal (local laboratory reference values).
  28. Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values) Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment
  29. Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age.

    After LCD phase (in adults):

  30. Failure to reach at least 8% weight reduction during the LCD phase. This leads to exclusion from the intervention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777893

Contacts
Contact: Anne B Raben, Professor +4535333653 ara@life.ku.dk
Contact: Thomas M Larsen, Associate professor +4535332505 tml@life.ku.dk

Locations
Australia
University of Sydney Recruiting
Sydney, Australia, NSW 2006
Contact: Jennie Brand-Miller, Professor    +61- 2 9351 3759    jennie.brandmiller@sydney.edu.au   
Bulgaria
Medical University Sofia Recruiting
Sofia, Bulgaria, 1403
Contact: Svetoslav Handjiev, Professor    +359 - 888 56 64 20    svhandjiev@gmail.com   
Contact: Teodorah Handjieva-Darlenska, PhD    + 359 - 897 95 54 10    teodorah@abv.bg   
Denmark
University of Copenhagen Recruiting
Frederiksberg, Denmark, 1958
Contact: Anne B. Raben, Professor    +4535333653    ara@life.ku.dk   
Contact: Thomas M. Larsen, Associate professor    +4535332505    tml@life.ku.dk   
Finland
University of Helsinki Recruiting
Helsinki, Finland, 00014
Contact: Mikael Fogelholm, Professor    +358 - 50 31 80 303    mikael.fogelholm@helsinki.fi   
Contact: Kirsi Pietiläinen, Ass. Professor    +358 - 50 59 92 295    kirsi.pietilainen@helsinki.fi   
Netherlands
Maastricht University Recruiting
MD Maastricht, Netherlands, 6200
Contact: Margriet Westerterp-Plantenga, Professor    +31 - 433 88 15 66    m.westerterp@maastrichtuniversity.nl   
Contact: Tanja Adam, PhD    +31 - 433 88 21 23    t.adam@maastrichtuniversity.nl   
New Zealand
University of Auckland Recruiting
Auckland, New Zealand, 1024
Contact: Sally D Poppitt, Professor    +64 - 96305764    s.poppitt@auckland.ac.nz   
Spain
University of Navarra Recruiting
Pamplona, Spain, 31008
Contact: J. Alfredo Martinez, Professor    +34 - 948 42 56 00    jalfmtz@unav.es   
Contact: Santiago Navas-Carretero, PhD    +34 948 42 56 00    snavas@unav.es   
United Kingdom
University of Nottingham Medical School Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Ian McDonald, Professor    +44 - 11 58 23 01 19    ian.macdonald@nottingham.ac.uk   
Contact: Elizabeth Simpson, PhD    +44 - 11 58 23 01 28    liz.simpson@nottingham.ac.uk   
Sponsors and Collaborators
Anne Birgitte Raben
Helsinki University
Maastricht University
University of Nottingham
University of Navarra
Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria
University of Sydney
University of Auckland, New Zealand
University of Stuttgart
Swansea University
Cambridge Manufacturing Company Limited
European Union
Investigators
Principal Investigator: Thomas M Larsen, Associate Professor University of Copenhagen
Principal Investigator: Mikael Fogelholm, Professor Helsinki University
Principal Investigator: Margriet Westerterp-Plantenga, Professor Maastricht University
Principal Investigator: Ian McDonald, Professor University of Nottingham Medical School
Principal Investigator: J. Alfredo Martinez, Professor University of Navarra
Principal Investigator: Svetoslav Handjiev, Professor Medical University Sofia
Principal Investigator: Jennie Brand-Miller, Professor University of Sydney
Principal Investigator: Sally D. Poppitt, Professor University of Auckland, New Zealand
  More Information

Additional Information:
No publications provided

Responsible Party: Anne Birgitte Raben, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01777893     History of Changes
Other Study ID Numbers: B303, 312057
Study First Received: January 24, 2013
Last Updated: January 27, 2014
Health Authority: Finland: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Research Ethics Committee
Spain: Ethics Committee
Bulgaria: Ethics committee
Australia: Human Research Ethics Committee
New Zealand: Health and Disability Ethics Committees

Keywords provided by University of Copenhagen:
Type-2 diabetes mellitus
Obesity
High protein diet
Low GI
Physical activity

Additional relevant MeSH terms:
Nutrition Disorders
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on July 22, 2014