NCT02493309

Brief Summary

The purpose of this study is to determine whether an individuals cardio-respiratory fitness level can protect them from the negative metabolic impacts of prolonged sitting time. Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will not be as substantial, nor will light activity breaks be as advantageous, compared to individuals with lower fitness as they have a smaller scope for metabolic improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable diabetes

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 30, 2020

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

July 6, 2015

Last Update Submit

January 29, 2020

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood glucose Area Under the Curve (AUC)

    Blood glucose AUC refers to the spike of an individuals blood sugar following a meal, the aim of which is to reduce the spike and consequently reduce the area under the curve.

    Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period

Secondary Outcomes (3)

  • Blood Triglyceride AUC

    Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period

  • Insulin AUC

    Assessed via 11 blood samples throughout each treatment condition throughout the 7.5 hour period

  • Blood Pressure

    Taken immediately before each blood sample is taken.

Study Arms (2)

Prolonged sitting

EXPERIMENTAL
Other: Prolonged sitting

Light activity breaks

ACTIVE COMPARATOR
Other: Light activity breaks

Interventions

Prolonged sittingOTHER

Condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period.

Prolonged sitting
Light activity breaksOTHER

Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.

Light activity breaks

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study
  • Body Mass Index: 20 - 30 kg/m2
  • Male and Female
  • Aged: ≥ 25 to ≤ 55 years of age.
  • Occupation: Work full-time in a predominantly sedentary occupation.

You may not qualify if:

  • The participant may not enter the study if ANY of the following apply:
  • Aged \<25 or \>55 years of age.
  • Physical condition which limits full participation in the study
  • Active psychotic illness or other significant illness which, in the view of the investigators, would prevent full participation
  • Inability to communicate in spoken English
  • Steroid use
  • Known Type 2 Diabetes
  • Pre-existing Cardio-vascular Disease (disease of the heart or blood vessels at present or in the past) For example: Heart attack, Stroke or Angina.
  • Pregnancy
  • Smoker
  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leicester Diabetes Centre, Leicester General Hospital

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas Yates, PhD

    University of Leicester

    PRINCIPAL INVESTIGATOR

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

July 6, 2015

First Posted

July 9, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 30, 2020

Record last verified: 2014-10

Locations

GB(1)