NCT02394249

Brief Summary

Background of the study: A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be spent. Several recent epidemiologic studies suggest that excessive sitting, independent of moderate to vigorous physical activity, has detrimental health effects. Another possibility to sit less is by increasing low intensity physical activities as slowly walking and standing. A recent published study of Duvivier and colleagues suggests that sitting less and replacing it by slowly walking and standing has a better effect on insulin action and cardiovascular risk factors than the combination of one hour MVPA per day and sitting the rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research is not performed in subjects with overweight/obesity. Objective of the study: To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity Study population: 21 subjects between 40-80 years old with overweight/obesity Intervention: 2 activity regimes of 4 days: a sitting regime and a "sit less" regime

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

February 19, 2015

Last Update Submit

March 15, 2016

Conditions

OverweightObesity

Keywords

Insulin ResistanceCognitionAffectInsulinLipids

Outcome Measures

Primary Outcomes (1)

  • Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)

    To assess the effect of low intensity physical activity (LIPA) on plasma insulin levels (as measured as area under the curve during an oral glucose tolerance test)

    one day after each regime

Secondary Outcomes (31)

  • Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)

    one day after each regime

  • Plasma C-peptide

    one day after each regime

  • Plasma glucose levels

    one day after each regime

  • Plasma triglycerides

    one day after each regime

  • Plasma total cholesterol

    one day after each regime

  • +26 more secondary outcomes

Study Arms (2)

Sitting regime

EXPERIMENTAL

The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping.

Behavioral: Physical activity regime

Sit Less regime

EXPERIMENTAL

Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 4 hours walking, 3 hours standing and 8 hours sleeping. The walking and standing will be done in a minimum of eight bouts with a time interval of \>1 hour. The subjects will be instructed to walk on a slow pace, i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc.

Behavioral: Physical activity regime

Interventions

Physical activity regimeBEHAVIORAL

Information already included in arm descriptions

Sit Less regimeSitting regime

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Men and postmenopausal women: 40-80 years old
  • BMI: 25.0 - 35.0 kg/m2
  • Maximum 2.5 hours of MVPA per week (during last 3 months)
  • Having a general practitioner
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Accessible veins on arms as determined by examination at screening

You may not qualify if:

  • Reported participation in another biomedical trial which may have an effect on insulin sensitivity one month before the pre-study examination or during the study
  • Blood donation in the past three months
  • Reported participation in night shift work 2 weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
  • Consumption of \>14 (women) or \> 21 (men) alcoholic units per week
  • Reported dietary habits: medically prescribed diet, slimming diet;
  • Reported weight loss (\>2kg) in the last three months prior to the screening;
  • Not being able to execute at least three (out of four) cognition tests in the training session
  • Not being able to execute the sit less try-out day
  • Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre
  • Experimental drug use (during the last 3 months)
  • Use of insulin, oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors), corticosteroids or vitamin K antagonists in the last 3 months
  • Fasting plasma glucose level \> 6.9 mmol/L
  • Medical conditions which make participation in the study not responsible which will be decided by a medical doctor during screening
  • Other clinically relevant abnormalities in clinical chemistry at screening (to be judged by a medical doctor)
  • Mental or physical disability which interferes with physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Movement Science, Maastricht University

Maastricht, Maastricht, 6200MD, Netherlands

Location

Related Publications (1)

  • Duvivier BM, Schaper NC, Bremers MA, van Crombrugge G, Menheere PP, Kars M, Savelberg HH. Minimal intensity physical activity (standing and walking) of longer duration improves insulin action and plasma lipids more than shorter periods of moderate to vigorous exercise (cycling) in sedentary subjects when energy expenditure is comparable. PLoS One. 2013;8(2):e55542. doi: 10.1371/journal.pone.0055542. Epub 2013 Feb 13.

    PMID: 23418444BACKGROUND

Related Links

MeSH Terms

Conditions

OverweightObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Hans H Savelberg, PhD

    Maastricht University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 20, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

NL(1)