NCT03912922

Brief Summary

Research has shown that replacing sitting time with low intensity physical activity (such as slowly walking and standing) has beneficial effects on metabolic health, like insulin sensitivity, comparable to improvements after sitting all day in combination with 1h streneous exercise. The main objective of this study is to investigate the underlying mechanisms responsible for improved insulin sensitivity after 4 days of sitting less compared to sitting and exercise in healthy obese women. Our secondary objective is to investigate the effects of sitting less on cardio metabolic parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration 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

December 15, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

April 3, 2019

Last Update Submit

January 19, 2021

Conditions

Keywords

insulin sensitivitysitting time

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    2-step hyperinsulinemic euglycemic clamp

    Day 5 of intervention period

Secondary Outcomes (5)

  • ex vivo skeletal muscle mitochondrial respiration

    Day 5 of intervention period

  • substrate oxidation

    Day 5 of intervention period

  • Intrahepatic lipid content

    Day 5 of intervention period

  • Blood pressure

    Day 5 of intervention period

  • Plasma cardio metabolic markers

    Day 5 of intervention period

Study Arms (3)

Sit regime

EXPERIMENTAL

Subjects will follow the sit regime during four days. Each day consists of 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping.

Other: Activity regime

Sit less regime

EXPERIMENTAL

Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 3 hours walking, 4 hours standing and 8 hours sleeping.

Other: Activity regime

Exercise regime

EXPERIMENTAL

Subjects will follow the exercise regime during four days. Each day will consist of 13 hours sitting, 1 hour walking, 1 hour standing, 1 hour exercise and 8 hours sleeping. The cycle session will be at approximately 60% maximal power. Exact cycling intensity and duration will be calculated to ensure equal total energy expenditure between the sitting less and the exercise regime.

Other: Activity regime

Interventions

Activity regime of 4 days followed by a test day.

Exercise regimeSit less regimeSit regime

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Caucasian
  • Postmenopausal women
  • Aged 45-70 years at start of the study
  • Body mass index (BMI) 25 - 35 kg/m2
  • Stable dietary habits (no weight loss or gain \>5kg in the past 3 months)
  • Sedentary lifestyle (not more than 2,5 hours of exercise per week in the past 3 months)

You may not qualify if:

  • Not able to complete the sitless try-out day according to the protocol
  • Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
  • No use of medication interfering with investigated study parameters (as determined by responsible physician)
  • Alcohol consumption of \>2 servings per day
  • Smoking in the past 6 months
  • Participation in another biomedical trial which may have an effect on insulin sensitivity less than one month before the start of the study (screening visit)
  • Mental or physical disability which interferes with physical activity
  • Subjects with contra-indications for magnetic resonance imaging (MRI)
  • Reported participation in night shift work 2 weeks prior to the start of the study (screening visit) and during study participation. Night work is defined as working between midnight and 6.00 AM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

  • Remie CME, Janssens GE, Bilet L, van Weeghel M, Duvivier BMFM, de Wit VHW, Connell NJ, Jorgensen JA, Schomakers BV, Schrauwen-Hinderling VB, Hoeks J, Hesselink MKC, Phielix E, Houtkooper RH, Schrauwen P. Sitting less elicits metabolic responses similar to exercise and enhances insulin sensitivity in postmenopausal women. Diabetologia. 2021 Dec;64(12):2817-2828. doi: 10.1007/s00125-021-05558-5. Epub 2021 Sep 12.

MeSH Terms

Conditions

OverweightObesityInsulin Resistance

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 11, 2019

Study Start

December 15, 2017

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations