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

This study is not yet open for participant recruitment.
Verified January 2013 by Maastricht University Medical Center
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01777893
First received: January 24, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

Type-2 diabetes (T2D), 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-project has been initialized to find out the most effective lifestyle-components (diet and physical activity) in the prevention of T2D. The entire project consists of a randomized lifestyle-intervention (PREVIEW-intervention) and a substudy assessing the role of sleep and neural adaptations for the relationship between intervention and the incidence of T2D.

Specifically, the aim of the PREVIEW-intervention is to determine the preventative impact of a high-protein and low-GI diet in combination with moderate or high intensity physical activity on the incidence of T2D in predisposed, pre-diabetic children, middle-aged and older adults . The Maastricht University will be a part of a randomized, controlled, multicentre trial (RCT) among participants at risk of developing diabetes (overweight with BMI > 25 kg/m2 and increased diabetes risk factors). The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain, Netherlands, UK), Australia and New Zealand. In a sub-study we will identify the mediating role of sleeping patterns (sleep quality and duration), stress and brain plasticity on the protein/ activity intervention and the outcome parameters.

The primary endpoint of the intervention study is the incidence of T2D during the 148 weeks after weight loss (high protein versus medium protein, adjusted to physical activity), based on a 75 g oral glucose tolerance test (OGTT). The incidence of diabetes will be assessed annually by participant self-report of medication requiring diabetes, doctor informed (and confirmed) diabetes diagnosis or diabetes diagnosed by fasting plasma glucose (FPG) and/or OGTT according to IDF guidelines. The main endpoint of the sub-study is the incidence of T2D 104 weeks after randomization (contrasting high vs. medium protein in the medium exercise group). For participating children the primary endpoint is a statistical, as well as physiological, improvement of health with respect to pre-diabetic characteristics (shown by the change in HOMA-IR and OGTT: fasting glucose level and 2h glucose level after oral glucose load).


Condition Intervention
Pre-diabetes
Obesity
Behavioral: High protein high intensity physical activity (HPHI)
Behavioral: High protein Medium intensity physical activity (HPMI)
Behavioral: Normal protein High intensity physical activity (NPHI)
Behavioral: Normal protein Medium intensity physical activity (NPMI)

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 Maastricht University Medical Center:

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

    Incidence of type 2 diabetes after randomization on high protein versus medium protein diet based on IDF criteria:

    Fasting plasma glucose >=7.0 mmol/l or 75 g oral glucose tolerance test with FPG >= 7.0 mmol/l and/or 2hour plasma glucose >=11.1 mmol/l or HbA1c >=6.5% or random plasma glucose >=11.1 mmol/l in the presence of classical diabetes symptoms

    for children: Change in glucose tolerance measured by HOMA-IR



Secondary Outcome Measures:
  • change in body fat mass [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    change in body fat mass assessed with BodPod.

  • sleeping pattern changes due to intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    it is hypothesized that a high-protein, low GI diet in interaction with physical activity may improve the sleeping pattern and reduce levels of chronic stress during the weight maintenance phase

  • changes in brain reward activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    it is hypothesized that brain reward activity in response to food cues will decrease in parallel with weight loss.


Estimated Enrollment: 275
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: HPHI
High protein/ high intensity physical activity
Behavioral: High protein high intensity physical activity (HPHI)
Participants will follow a high protein/ intense physical activity intervention
Active Comparator: HPMI
High protein/ medium intensity physical activity
Behavioral: High protein Medium intensity physical activity (HPMI)
Participants follow a high protein medium intensity physical activity intervention
Active Comparator: NPHI
normal protein/ high intensity physical activity
Behavioral: Normal protein High intensity physical activity (NPHI)
Participants follow a normal protein high intensity physical activity intervention
Active Comparator: NPMI
Normal protein/ normal intensity physical activity
Behavioral: Normal protein Medium intensity physical activity (NPMI)
Participants follow a normal protein medium 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. BMI>25 kg/m2
  2. Pre-diabetes (The criteria from 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). Due to potential between-lab variation (local assessments))

For children:

  1. Age-adjusted value corresponding to BMI>25 kg/m2 (Cole et al. 2000)
  2. 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 overweight/obese children, defined as a homeostasis model assessment of insulin resistance HOMA-IR >2 , will be included.

Exclusion Criteria:

  1. Use of prescription medication (including steroid inhalers and sprays), except stable antihypertensive medication, lipid lowering agents, and oral contraceptives.
  2. Thyroid diseases (auto-immune related hypothyroidism is allowed inclusion, if the participant is on stable thyroxine replacement for at least 3 months)
  3. Persons with any chronic disease making a 6-year survival improbable as well as other medical characteristics likely to interfere with participation in the study, including problems making participation in physical activity program risky or impossible;
  4. Participants engaged in competitive sports
  5. Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed.
  6. Severe food intolerance expected to interfere with the study
  7. Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women)
  8. Drug use
  9. Blood donation within the past 1 month before entering the study.
  10. Self-reported weight change of >5 kg within 2 months prior to screening (baseline) assessment (week 0)
  11. Psychiatric illness as defined by DSMIV or ICD10 criteria
  12. Self-reported eating disorders
  13. Pregnant or lactating women, or women who are planning to become pregnant within the next 36 months.
  14. Persons who do not have access to either (mobile) phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase)
  15. Insufficient communication with national language
  16. Past or present cancer (except basalioma and squamous skin cell cancer), which in the investigator's opionion could interfere with the results of the trial
  17. Previous history of bariatric surgery
  18. Chronic inflammatory bowel diseases or celiac disease
  19. Clinically significant active cardiovascular disease (myocardial infarction, stroke within the past 6 mo and/or heart failure)
  20. Failure to reach the 8% weight reduction during the LED-phase leads to exclusion from the intervention.
  21. Blood pressure is measured and those with systolic blood pressure, SBP, above 160 and diastolic blood pressure, DBP, above 100 mmHg are also excluded (participants with SBP=159 and/or DBP=99 are allowed inclusion). Well regulated BP (<140/90 mmHg) using drugs (except B-Blockers) is allowed if no change in BP and drug treatment within last 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777893

Contacts
Contact: Tanja C Adam, PhD +31433882123 t.adam@maastrichtuniversity.nl
Contact: Margriet S Westerterp-Plantenga, PhD +31433881566 m.westerterp@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Not yet recruiting
Maastricht, Netherlands, 6200 MD
Principal Investigator: Tanja C Adam, PhD            
Sponsors and Collaborators
Maastricht University Medical Center
European Union
Investigators
Principal Investigator: Tanja C Adam, PhD Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01777893     History of Changes
Other Study ID Numbers: 1-Adam
Study First Received: January 24, 2013
Last Updated: January 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
type 2 diabetes mellitus
obesity
high protein diet
physical activity
sleep
brain reward response

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

ClinicalTrials.gov processed this record on May 21, 2013