Arming Health: Can Breaking up Restful Sitting Time With Upper Body Contractile Activity Regulate Metabolic Health.

NCT02909894 | Completed

• 1 other identifier: 0548
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Research shows that sitting for long periods of time on a regular basis is bad for health and can leave individuals more susceptible to Obesity, Cardiovascular Disease, Type 2 Diabetes and premature death regardless of exercise engagement outside of these seated hours. As sitting is so common in modern society it is vital that research explores ways to protect individuals from this worsening issue. Investigators want to see if breaking up long periods of sitting time with short, frequent bouts of light physical activity, while remaining seated, is enough to alleviate these risk factors.

Conditions

Diabetes

Keywords

Sedentary behaviour; Postprandial glycaemic response

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 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for both of the two 7.5 hour experimental treatment conditions.

Secondary Outcomes (6)

• Insulin Area Under the Curve (AUC)

  Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for both of the two 7.5 hour experimental treatment conditions.

• Blood Pressure Area Under the Curve (AUC)

  Blood pressure measurements will be taken prior to each blood sample, therefore 10 measurements in total. Two measurements will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals.

• Cognitive function - Part 1 - Semantic verbal fluency test.

  This test will only take one minute in duration. It is administered on arrival at the laboratory (approximately 8am) and will be repeated later on in the day following the last blood sample (approximately 4pm).

• Cognitive function - Part 2 - Hopkins Verbal Learning test

  Participants will undertake this test in the morning, following part 1 of the cognitive test (immediate recall) and also at the end of the experimental day (delayed recall). A maximum of one minute is used to recall as many words as possible.

• Cognitive function - Part 3 - Trail Making

  The time taken to complete this test varies between individuals but on average takes approximately 5 minutes. Participants will undertake this test in the morning, (following part 2 of the cognitive test) and also at the end of the experimental visit.

Study Arms (2)

Prolonged Sitting

EXPERIMENTAL

Other: Prolonged Sitting

Light intensity arm ergometry breaks

ACTIVE COMPARATOR

Other: Light arm ergometry breaks

Interventions

Prolonged Sitting OTHER

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 investigators 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. Following this, a lunch meal will be provided and investigators will continue taking blood samples and blood pressure at 30, 60, 120 and 180 minutes after this lunch meal. In total, 10 blood samples will be taken over the 7 ½ hour testing period. There will also be a cognitive test in the morning and afternoon.

Prolonged Sitting

Light arm ergometry breaks OTHER

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 light intensity arm ergometry on a desktop arm ergometer every 30 minutes following breakfast and lunch. In total they will do 12 five minute arm ergometry breaks throughout the 7 ½ hour test period (60 minutes of arm ergometry in total). In total 10 blood samples will be taken on the day.

Light intensity arm ergometry breaks

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Body Mass Index: ≥ 30 kg/m2
• Male and Female
• Aged: ≥ 30 to ≤ 75 years of age.
• Inactive (I.e. no habitual structured exercise).
• Participant is able to walk (without any assistive devices)

You may not qualify if:

• Aged \< 30 or \> 75 years of age.
• Physical condition which limits full participation in the familiarisation visit or treatment visits.
• 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 Mellitus
• Pre-existing Cardio-vascular Disease including a previous heart attack, stroke, angina or coronary artery bypass surgery of cardiac stents.
• Pregnancy
• Smoker
• Terminal illness
• Contraindication to gas mask procedure (I.e. Claustrophobia).
• Chronic Obstructive Pulmonary Disease. (I.e. Chronic Bronchitis or Emphysema).

Sponsors & Collaborators

• University of Leicester: lead
• National Institute for Health Research, United Kingdom: collaborator
• National Health Service, United Kingdom: collaborator

Study Sites (1)

Leicester Diabetes Centre, Leicester General Hospital

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Related Publications (1)

• McCarthy M, Edwardson CL, Davies MJ, Henson J, Rowlands A, King JA, Bodicoat DH, Khunti K, Yates T. Breaking up sedentary time with seated upper body activity can regulate metabolic health in obese high-risk adults: A randomized crossover trial. Diabetes Obes Metab. 2017 Dec;19(12):1732-1739. doi: 10.1111/dom.13016. Epub 2017 Jul 20.

  PMID: 28544202 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 21, 2016
• Study Start: May 26, 2016
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: January 30, 2020

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)