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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01777893




Registration number
NCT01777893
Ethics application status
Date submitted
24/01/2013
Date registered
29/01/2013
Date last updated
20/03/2019

Titles & IDs
Public title
Effect of Diet and Physical Activity on Incidence of Type 2 Diabetes
Scientific title
PREVention of Diabetes Through Lifestyle Intervention and Population Studies in Europe and Around the World
Secondary ID [1] 0 0
312057
Secondary ID [2] 0 0
B303
Universal Trial Number (UTN)
Trial acronym
PREVIEW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 0 0
Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)

Experimental: HP-HI - High protein/ high intensity physical activity

Experimental: HP-MI - High protein/ moderate intensity physical activity

Experimental: MP-HI - Moderate protein/ high intensity physical activity

Experimental: MP-MI - Moderate protein/ moderate 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

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
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of type 2 diabetes
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Incidence of type-2 diabetes
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Change in HbA1c
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Change in body weight (kg or percent) and waist 8cm), hip (cm) and thigh circumference (cm)
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Change in body composition - fat mass and fat-free mass (kg, proportion of body weight)
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Proportion of subjects maintaining at least 0, 5 or 10% weight loss
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Insulin sensitivity (e.g Matsuda Index based on the OGTT, glucose area under the curve (AUC) during OGTT, beta-cell disposition index) (OGTT only adults)
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Risk factors for cardiovascular disease, with at least the following measures: blood pressure, heart rate, lipids (triglycerides, total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol), C-reactive protein, and liver enzymes
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Changes in dietary intake (4-d weighed food records)
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Changes in physical activity (accelerometers and questionnaires).
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Changes in perceived quality of life and workability, habitual well-being, sleep and chronic stress, subjective appetite sensations, dietary restraint, moderators, mediators, behavioral and social environment.
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
The effects of stature (height; proportion leg-length/height) in adults and changes in stature in children and adolescents, on the changes in relationship between reduction in body weight, body fat and insulin sensitivity
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Safety parameters (blood samples).
Timepoint [12] 0 0
Screening and during 3 years
Secondary outcome [13] 0 0
Adverse events and concomitant medication.
Timepoint [13] 0 0
Screening and during 3 years
Secondary outcome [14] 0 0
Compliance by urin samples for nitrogen analyses.
Timepoint [14] 0 0
3 years
Secondary outcome [15] 0 0
In a sub-group: Metabolomic profiling.
Timepoint [15] 0 0
3 years
Secondary outcome [16] 0 0
In a sub-group: DNA, RNA
Timepoint [16] 0 0
3 years
Secondary outcome [17] 0 0
In a sub-group: Colon cancer risk markers
Timepoint [17] 0 0
3 years
Secondary outcome [18] 0 0
In a sub-group: Kidney safety markers, body fat and liver-fat content.
Timepoint [18] 0 0
3 years
Secondary outcome [19] 0 0
In a sub-group: Body and liver-fat content.
Timepoint [19] 0 0
3 years
Secondary outcome [20] 0 0
In a sub-group: Changes in brain responses and cortical thickness
Timepoint [20] 0 0
2 years
Secondary outcome [21] 0 0
In a sub-group: Changes in 48-h energy expenditure in a respiration chamber setting
Timepoint [21] 0 0
3 years
Secondary outcome [22] 0 0
In a sub-group: Gut microbiome
Timepoint [22] 0 0
3 years
Secondary outcome [23] 0 0
In a sub-group: Circulating amino acids
Timepoint [23] 0 0
8 wks
Secondary outcome [24] 0 0
In a sub-group: Plasma mitochondrial peptides
Timepoint [24] 0 0
8 wks
Secondary outcome [25] 0 0
In a sub-group: Insulin Growth factor 2 (IGF-II) and IGF-II receptor (IGF2R)
Timepoint [25] 0 0
8 wks

Eligibility
Key inclusion criteria
For adults:

1. Age 25 - 70 years:

From mid 2013 - mid 2014, subjects aged 25-45 and 55-70 years were enrolled. From mid 2014, subjects aged 46-54 years were also enrolled.
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 (at screening), 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 = 2.0 for Tanner stage > 2. No HOMA criteria is used for Tanner stage 1 and 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.
Minimum age
10 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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. Having normal (i.e. not prediabetic) glucose concentrations at 0 and 2h of OGTT at any stage of the study is not an exclusion criterion.

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.

Note:

* The listed inclusion and exclusion criteria are applied at screening;
* Having normal (i.e. not pre-diabetic) glucose concentrations at 0 and 2 h of OGTT at any stage of the study after screening is not an exclusion criterion

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Denmark
State/province [2] 0 0
Frederiksberg
Country [3] 0 0
Finland
State/province [3] 0 0
Helsinki
Country [4] 0 0
Netherlands
State/province [4] 0 0
Maastricht
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
Spain
State/province [6] 0 0
Pamplona
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Nottingham
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Other
Name
Anne Birgitte Raben
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Helsinki
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Maastricht University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Nottingham
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Navarra
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Sydney
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Auckland, New Zealand
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University of Stuttgart
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Swansea University
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Commercial sector/industry
Name [10] 0 0
Cambridge Manufacturing Company Limited
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
European Union
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Wageningen University
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Meyers Madhus
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
NetUnion SARL
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Terveyden Ja Hyvinvoinnin Laitos
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Laval University
Address [16] 0 0
Country [16] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas M Larsen, Ass. Prof.
Address 0 0
University of Copenhagen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01777893