Role of Interrupting Sedentary Time in Management of Type-2 Diabetes

NCT02738996 | Unknown

• 1 other identifier: Just_StandUp
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function and insulin production in the body. In type-2 diabetic patients, postprandial glucose control, lipid control and reduction of insulin resistance are crucial to deter the development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently, diet, exercise and standard oral medicines are used to treat type-2 diabetes. However, providing the most effective treatment to control postprandial glucose and lipid; and to preserve the pancreatic β cells is challenging because poor metabolic profiles are still detected in type-2 diabetic patients. Therefore, understanding the factors influencing the poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important to tackle this disease. In modern society, people are spending most of their waking time in sedentary behaviour, which is primarily prolonged sitting. Prolonged sedentary time is associated with increased postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of prolonged sitting with short light activity break reduces postprandial glucose, triglyceride cholesterol and insulin resistance. However, how frequently patients should interrupt sitting, potential longer-term effect of short activity break on reduction of postprandial glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and experiences on the use of technology to decrease sedentary behaviour and improve glycaemic control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to investigate this to prove the therapeutic role of frequent short activity break in sedentary time in the management of type-2 diabetes. Primary Research Objective:

1. 1.To investigate the dose-response effect of frequency/number of light intensity walking breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride cholesterol level.
2. 2.To investigate the potential longer-term effect of light intensity walking breaks of sitting on glucose control using 24-h glucose data.
3. 3.To obtain data to inform the development of a future feasibility trial investigating the feasibility, compliance, adherence and longer-term effect of different frequencies of light intensity walking breaks in sitting time on glycaemic excursions in free-living.
4. 4.To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control, that could be used in the feasibility trial

Conditions

Diabetes

Keywords

Diabetes; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose excursions measured with Area under curve

  Dose-response relationship between frequencies of short light activity breaks in sedentary time and postprandial glucose excursions

  8 hours

Secondary Outcomes (3)

• 24 hours glucose profile measured with continuous glucose monitor LifeStyle Libre

  24 hours

• Insulin, C-peptide and triglyceride cholesterol plasma level during the intervention measured with Area under curve

  8 hours

• Qualitative exploration of the knowledge, beliefs and experiences of those with type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control

  1 hour

Study Arms (6)

60-30 min

EXPERIMENTAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min and 30 min

Behavioral: Sedentary time breaks either every 60 minutes; Behavioral: Sedentary time breaks either every 30 minutes

30-15 min

EXPERIMENTAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min and 15 min

Behavioral: Sedentary time breaks either every 30 minutes; Behavioral: Sedentary time breaks every 15 minutes

15-60 min

EXPERIMENTAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min and 60 min

Behavioral: Sedentary time breaks either every 60 minutes; Behavioral: Sedentary time breaks every 15 minutes

60-15

EXPERIMENTAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min and 15 min

Behavioral: Sedentary time breaks either every 60 minutes; Behavioral: Sedentary time breaks every 15 minutes

30-60 min

EXPERIMENTAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min and 60 min

Behavioral: Sedentary time breaks either every 60 minutes; Behavioral: Sedentary time breaks either every 30 minutes

15-30 min

EXPERIMENTAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min and 30 min

Behavioral: Sedentary time breaks either every 30 minutes; Behavioral: Sedentary time breaks every 15 minutes

Interventions

Sedentary time breaks either every 60 minutes BEHAVIORAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min

Also known as: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every

15-60 min; 30-60 min; 60-15; 60-30 min

Sedentary time breaks either every 30 minutes BEHAVIORAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min

Also known as: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min

15-30 min; 30-15 min; 30-60 min; 60-30 min

Sedentary time breaks every 15 minutes BEHAVIORAL

Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min

Also known as: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks either every 15 minutes

15-30 min; 15-60 min; 30-15 min; 60-15

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals with type 2 diabetes for less than 10 years
• Individuals aged 35-60 years
• Individuals receiving metformin or diet control
• Non-smokers
• Overweight and obese individuals (BMI 25-35 kg/m2)
• Individuals with an HbA1c between \>7%
• Individuals with BP below 160/90mmHg

You may not qualify if:

• Individuals unable or unwilling to consent
• Individuals under the age of 35 years and over the age of 60 years at study enrolment
• Patients on sulphonylurea or other oral hypoglycaemic drugs therapy except metformin
• Individuals with hepatic or renal dysfunction
• Individuals with body mass index greater than 35
• Individuals suffering from cancer, cardiovascular diseases, cirrhosis, hepatitis and renal disease
• Pregnant Individuals
• Individuals who smoke
• Individuals who are alcohol and drug abusers
• Individuals with a blood pressure ≥160/90mmHg
• Individuals diagnosed with anaemia (Hb\<12g/dl in women and \<13 g/dl in men)
• Individuals taking medicines which can interfere with the glucose metabolism (e.g. anticoagulants, oral contraceptives, steroid, thiazide, β-blocker, NSAID, anti-fungal, hormonal therapy, psychotropic drugs)
• Individual taking drugs for glycaemic control in excess of standard care highlighted by the SIGN guideline 116.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• University of Strathclyde: collaborator

Related Publications (9)

• Chastin SF, Egerton T, Leask C, Stamatakis E. Meta-analysis of the relationship between breaks in sedentary behavior and cardiometabolic health. Obesity (Silver Spring). 2015 Sep;23(9):1800-10. doi: 10.1002/oby.21180.

  PMID: 26308477 BACKGROUND

• Cooper AR, Sebire S, Montgomery AA, Peters TJ, Sharp DJ, Jackson N, Fitzsimons K, Dayan CM, Andrews RC. Sedentary time, breaks in sedentary time and metabolic variables in people with newly diagnosed type 2 diabetes. Diabetologia. 2012 Mar;55(3):589-99. doi: 10.1007/s00125-011-2408-x. Epub 2011 Dec 14.

  PMID: 22167127 BACKGROUND

• Dempsey, P.C., Owen, N., Larsen, R., Straznicky, N., Cohen, Neale., FACSM, B.B., Kingwell, B.A., Dunstan, D.W., Baker IDI Heart and Diabetes Institute, Melbourne, Australia., Department of Health and Exercise Science, Colorado State University, Fort Collins, Colorado, USA. 2015. Interrupting Prolonged Sitting: A Potential Therapeutic Tool in the Management of Type 2 Diabetes

  BACKGROUND

• Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.

  PMID: 22374636 BACKGROUND

• Healy GN, Dunstan DW, Salmon J, Cerin E, Shaw JE, Zimmet PZ, Owen N. Breaks in sedentary time: beneficial associations with metabolic risk. Diabetes Care. 2008 Apr;31(4):661-6. doi: 10.2337/dc07-2046. Epub 2008 Feb 5.

  PMID: 18252901 BACKGROUND

• Henson J, Yates T, Biddle SJ, Edwardson CL, Khunti K, Wilmot EG, Gray LJ, Gorely T, Nimmo MA, Davies MJ. Associations of objectively measured sedentary behaviour and physical activity with markers of cardiometabolic health. Diabetologia. 2013 May;56(5):1012-20. doi: 10.1007/s00125-013-2845-9. Epub 2013 Mar 1.

  PMID: 23456209 BACKGROUND

• Latouche C, Jowett JB, Carey AL, Bertovic DA, Owen N, Dunstan DW, Kingwell BA. Effects of breaking up prolonged sitting on skeletal muscle gene expression. J Appl Physiol (1985). 2013 Feb 15;114(4):453-60. doi: 10.1152/japplphysiol.00978.2012. Epub 2012 Dec 27.

  PMID: 23271697 BACKGROUND

• Peddie MC, Bone JL, Rehrer NJ, Skeaff CM, Gray AR, Perry TL. Breaking prolonged sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized crossover trial. Am J Clin Nutr. 2013 Aug;98(2):358-66. doi: 10.3945/ajcn.112.051763. Epub 2013 Jun 26.

  PMID: 23803893 BACKGROUND

• Paing AC, McMillan KA, Kirk AF, Collier A, Hewitt A, Chastin SFM. Dose-response between frequency of interruption of sedentary time and fasting glucose, the dawn phenomenon and night-time glucose in Type 2 diabetes. Diabet Med. 2019 Mar;36(3):376-382. doi: 10.1111/dme.13829. Epub 2018 Oct 12.

  PMID: 30264906 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Sedentary Behavior

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrew Collier,, MBchb

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Chastin, PhD

CONTACT

441413313744; Sebastien.Chastin@gcu.ac.uk

Aye Paing, MBBS

CONTACT

441413313357; ayechan.paing@gcu.ac.uk

Study Design

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

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 14, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share